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1.  Operative Technique and Clinical Outcome in Endoscopic Core Decompression of Osteochondral Lesions of the Talus: A Pilot Study 
Revitalizing the necrotic subchondral bone and preserving the intact cartilage layer by retrograde drilling is the preferred option for treatment of undetached osteochondral lesions of the talus (OLT). We assessed the effectiveness of Endoscopic Core Decompression (ECD) in treatment of OLT.
Seven patients with an undetached OLT of the medial talar dome underwent surgical treatment using an arthroscopically-guided transtalar drill meatus for core decompression of the lesion. Under endoscopic visualization the OLT was completely debrided while preserving the cartilage layer covering the defect. The drill tunnel and debrided OLT were filled using an injectable bone graft substitute. Various clinical scores, radiographic imaging, and MRI were evaluated after a mean follow-up of 24.1 months.
The American Orthopedic Foot and Ankle Society Score significantly improved from 71.0±2.4 to 90.3±5.9, and the Foot and Ankle Disability Index improved from 71.8±11.1 to 91.7±4.8. Radiographically, we observed good bone remodelling of the medial talar dome contour within 3 months. In MRI, an alteration of the bony signal of the drill tunnel and the excised OLT remained for more than 12 months.
First follow-up results for the surgical technique described in this study are highly promising for treatment of undetached stable OLT grade II or transitional stage II–III according to the Pritsch classification. Even lesions larger than 150 mm2 showed good clinical scores, with full restoration of the medial talar dome contour in radiographic imaging.
PMCID: PMC4933542  PMID: 27362485
Ankle Joint; Arthroplasty, Subchondral; Arthroscopy; Bone Cysts; Osteonecrosis; Talus
2.  Computed tomography analysis of osteochondral defects of the talus after arthroscopic debridement and microfracture 
The primary surgical treatment of osteochondral defects (OCD) of the talus is arthroscopic debridement and microfracture. Healing of the subchondral bone is important because it affects cartilage repair and thus plays a role in pathogenesis of osteoarthritis. The purpose of this study was to evaluate the dimensional changes and bony healing of talar OCDs after arthroscopic debridement and microfracture.
Fifty-eight patients with a talar OCD were treated with arthroscopic debridement and microfracture. Computed tomography (CT) scans were obtained at baseline, 2 weeks postoperatively, and 1 year postoperatively. Three-dimensional changes and bony healing were analysed on CT scans. Additionally, clinical outcome was measured with the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score and numeric rating scales (NRS) for pain.
Average OCD size increased significantly (p < 0.001) in all directions from 8.6 (SD 3.6) × 6.3 (SD 2.6) × 4.8 (SD 2.3) mm (anterior–posterior × medial–lateral × depth) preoperatively to 11.3 (SD 3.4) × 7.9 (SD 2.8) × 5.8 (SD 2.3) mm 2 weeks postoperatively. At 1-year follow-up, average defect size was 8.3 (SD 4.2) × 5.7 (SD 3.0) × 3.6 (SD 2.4) mm. Only average defect depth decreased significantly (p < 0.001) from preoperative to 1 year postoperative. Fourteen of the 58 OCDs were well healed. No significant differences in the AOFAS and NRS-pain were found between the well and poorly healed OCDs.
Arthroscopic debridement and microfracture of a talar OCD leads to an increased defect size on the direct postoperative CT scan but restores at 1-year follow-up. Only fourteen of the 58 OCDs were filled up completely, but no differences were found between the clinical outcomes and defect healing at 1-year follow-up.
Level of evidence
PMCID: PMC4823333  PMID: 26713327
Osteochondral defect; Subchondral bone; Cyst; Ankle; Arthroscopy; Microfracture
3.  Tertiary osteochondral defect of the talus treated by a novel contoured metal implant 
The primary treatment of most osteochondral defects of the talus is arthroscopic debridement and bone marrow stimulation. There is no optimal treatment for large lesions or for those in which primary treatment has failed. We report a 20-year-old female patient with persistent symptoms after two previous arthroscopic procedures. Computed tomography showed a cystic defect of the medial talar dome, sized 17 × 8 × 8 mm. The patient was treated with a novel contoured metal implant. At 1 and 2 years after surgery, the patient reported considerable reduction in pain and had resumed playing korfball at competitive level.
Level of evidence IV.
PMCID: PMC3096766  PMID: 21409468
Osteochondral lesions; Bone cyst; Talus; Ankle; Metal implant; Treatment
4.  CAM-Type Impingement in the Ankle 
Anterior ankle impingement with and without ankle osteoarthritis (OA) is a common condition. Bony impingement between the distal tibia and talus aggravated by dorsiflexion has been well described. The etiology of these impingement lesions remains controversial. This study describes a cam-type impingement of the ankle, in which the sagittal contour of the talar dome is a non-circular arc, causing pathologic contact with the anterior aspect of the tibial plafond during dorsiflexion, leading to abnormal ankle joint mechanics by limiting dorsiflexion.
A group of 269 consecutive adult patients from the University of Iowa Hospitals and Clinics who were treated for anterior bony impingement syndrome were evaluated as the study population. As a control group, 41 patients without any evidence of impingement or arthrosis were evaluated. Standardized standing lateral ankle radiographs were evaluated to determine the contour of the head/neck relationship in the talus. Two investigators made all the radiographic measurements and intra- and inter-observer reliability were measured.
34% of patients were found to have some anterior extension of the talar dome creating a loss of the normal concavity at the dorsal medial talar neck. A group of 36 patients (13%) were identified as having the most severe cam deformity in order to assess any correlation with coexisting radiographic abnormalities. In these patients, a cavo-varus foot type was more commonly observed. Comparison with a control group showed much lower rates of anterior-medial cam-type deformity of the talus.
Cam type impingement of the ankle is likely a distinct form of bony impingement of the ankle secondary to a morphological talar bony abnormality. Based on the findings of this study, this form of impingement may be related to a cavovarus foot type. In addition, there may be long term implications in the development of ankle OA.
Level of Evidence
Level III
PMCID: PMC3565388  PMID: 23576914
5.  Intrastromal Corneal Ring Implants for Corneal Thinning Disorders 
Executive Summary
The purpose of this project was to determine the role of corneal implants in the management of corneal thinning disease conditions. An evidence-based review was conducted to determine the safety, effectiveness and durability of corneal implants for the management of corneal thinning disorders. The evolving directions of research in this area were also reviewed.
Subject of the Evidence-Based Analysis
The primary treatment objectives for corneal implants are to normalize corneal surface topography, improve contact lens tolerability, and restore visual acuity in order to delay or defer the need for corneal transplant. Implant placement is a minimally invasive procedure that is purported to be safe and effective. The procedure is also claimed to be adjustable, reversible, and both eyes can be treated at the same time. Further, implants do not limit the performance of subsequent surgical approaches or interfere with corneal transplant. The evidence for these claims is the focus of this review.
The specific research questions for the evidence review were as follows:
Corneal Surface Topographic Effects:
Effects on corneal surface remodelling
Impact of these changes on subsequent interventions, particularly corneal transplantation (penetrating keratoplasty [PKP])
Visual Acuity
Refractive Outcomes
Visual Quality (Symptoms): such as contrast vision or decreased visual symptoms (halos, fluctuating vision)
Contact lens tolerance
Functional visual rehabilitation and quality of life
Patient satisfaction:
Disease Process:
Impact on corneal thinning process
Effect on delaying or deferring the need for corneal transplantation
Clinical Need: Target Population and Condition
Corneal ectasia (thinning) comprises a range of disorders involving either primary disease conditions such as keratoconus and pellucid marginal corneal degeneration or secondary iatrogenic conditions such as corneal thinning occurring after LASIK refractive surgery. The condition occurs when the normally round dome-shaped cornea progressively thins causing a cone-like bulge or forward protrusion in response to the normal pressure of the eye. Thinning occurs primarily in the stoma layers and is believed to be a breakdown in the collagen network. This bulging can lead to an irregular shape or astigmatism of the cornea and, because the anterior part of the cornea is largely responsible for the focusing of light on the retina, results in loss of visual acuity. This can make even simple daily tasks, such as driving, watching television or reading, difficult to perform.
Keratoconus (KC) is the most common form of corneal thinning disorder and is a noninflammatory chronic disease process. Although the specific causes of the biomechanical alterations that occur in KC are unknown, there is a growing body of evidence to suggest that genetic factors may play an important role. KC is a rare condition (<0.05% of the population) and is unique among chronic eye diseases as it has an early age of onset (median age of 25 years). Disease management for this condition follows a step-wise approach depending on disease severity. Contact lenses are the primary treatment of choice when there is irregular astigmatism associated with the disease. When patients can no longer tolerate contact lenses or when lenses no longer provide adequate vision, patients are referred for corneal transplant.
Keratoconus is one of the leading indications for corneal transplants and has been so for the last three decades. Yet, despite high graft survival rates of up to 20 years, there are reasons to defer receiving transplants for as long as possible. Patients with keratoconus are generally young and life-long term graft survival would be an important consideration. The surgery itself involves lengthy time off work and there are potential complications from long term steroid use following surgery, as well as the risk of developing secondary cataracts, glaucoma etc. After transplant, recurrent KC is possible with need for subsequent intervention. Residual refractive errors and astigmatism can remain challenging after transplantation and high refractive surgery rates and re-graft rates in KC patients have been reported. Visual rehabilitation or recovery of visual acuity after transplant may be slow and/or unsatisfactory to patients.
Description of Technology/Therapy
INTACS® (Addition Technology Inc. Sunnyvale, CA, formerly KeraVision, Inc.) are the only currently licensed corneal implants in Canada. The implants are micro-thin poly methyl methacrylate crescent shaped ring segments with a circumference arc length of 150 degrees, an external diameter of 8.10 mm, an inner diameter of 6.77 mm, and a range of different thicknesses. Implants act as passive spacers and, when placed in the cornea, cause local separation of the corneal lamellae resulting in a shortening of the arc length of the anterior corneal curvature and flattening the central cornea. Increasing segment thickness results in greater lamellar separation with increased flattening of the cornea correcting for myopia by decreasing the optical power of the eye. Corneal implants also improve corneal astigmatism but the mechanism of action for this is less well understood.
Treatment with corneal implants is considered for patients who are contact lens intolerant, having adequate corneal thickness particularly around the area of the implant incision site and without central corneal scarring. Those with central corneal scarring would not benefit from implants and those without an adequate corneal thickness, particularly in the region that the implants are being inserted, would be at increased risk for corneal perforation. Patients desiring to have visual rehabilitation that does not include glasses or contact lenses would not be candidates for corneal ring implants.
Placement of the implants is an outpatient procedure with topical anesthesia generally performed by either corneal specialists or refractive surgeons. It involves creating tunnels in the corneal stroma to secure the implants either by a diamond knife or laser calibrated to an approximate depth of 70% of the cornea. Variable approaches have been employed by surgeons in selecting ring segment size, number and position. Generally, two segments of equal thickness are placed superiorly and inferiorly to manage symmetrical patterns of corneal thinning whereas one segment may be placed to manage asymmetric thinning patterns.
Following implantation, the major safety concerns are for potential adverse events including corneal perforation, infection, corneal infiltrates, corneal neovascularization, ring migration and extrusion and corneal thinning. Technical results can be unsatisfactory for several reasons. Treatment may result in an over or under-correction of refraction and may induce astigmatism or asymmetry of the cornea.
Progression of the corneal cone with corneal opacities is also invariably an indication for progression to corneal transplant. Other reasons for treatment failure or patient dissatisfaction include foreign body sensation, unsatisfactory visual quality with symptoms such as double vision, fluctuating vision, poor night vision or visual side effects related to ring edge or induced or unresolved astigmatism.
Evidence-Based Analysis Methods
The literature search strategy employed keywords and subject headings to capture the concepts of 1) intrastromal corneal rings and 2) corneal diseases, with a focus on keratoconus, astigmatism, and corneal ectasia. The initial search was run on April 17, 2008, and a final search was run on March 6, 2009 in the following databases: Ovid MEDLINE (1996 to February Week 4 2009), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2009 Week 10), OVID Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 2000 and April 17, 2008. The resulting citations were downloaded into Reference Manager, v.11 (ISI Researchsoft, Thomson Scientific, U.S.A), and duplicates were removed. The Web sites of several other health technology agencies were also reviewed including the Canadian Agency for Drugs and Technologies in Health (CADTH), ECRI, and the United Kingdom National Institute for Clinical Excellence (NICE). The bibliographies of relevant articles were scanned.
Inclusion Criteria
English language reports and human studies
Any corneal thinning disorder
Reports with corneal implants used alone or in conjunction with other interventions
Original reports with defined study methodology
Reports including standardized measurements on outcome events such as technical success, safety, effectiveness, durability, vision quality of life or patient satisfaction
Case reports or case series for complications and adverse events
Exclusion Criteria
Non-systematic reviews, letters, comments and editorials
Reports not involving outcome events such as safety, effectiveness, durability, vision quality or patient satisfaction following an intervention with corneal implants
Reports not involving corneal thinning disorders and an intervention with corneal implants
Summary of Findings
In the MAS evidence review on intrastromal corneal ring implants, 66 reports were identified on the use of implants for management of corneal thinning disorders. Reports varied according to their primary clinical indication, type of corneal implant, and whether or not secondary procedures were used in conjunction with the implants. Implants were reported to manage post LASIK thinning and/or uncorrected refractive error and were also reported as an adjunctive intervention both during and after corneal transplant to manage recurrent thinning and/or uncorrected refractive error.
Ten pre-post cohort longitudinal follow-up studies were identified examining the safety and effectiveness of INTAC corneal implants in patients with keratoconus. Five additional cohort studies were identified using the Ferrara implant for keratoconus management but because this corneal implant is not licensed in Canada these studies were not reviewed.
The cohorts implanted with INTACS involved 608 keratoconus patients (754 eyes) followed for 1, 2 or 3 years. Three of the reports involved ≥ 2 years of follow-up with the longest having 5-year follow-up data for a small number of patients. Four of the INTAC cohort studies involved 50 or more patients; the largest involved 255 patients. Inclusion criteria for the studies were consistent and included patients who were contact lens intolerant, had adequate corneal thickness, particularly around the area of the implant incision site, and without central corneal scarring. Disease severity, thinning pattern, and corneal cone protrusions all varied and generally required different treatment approaches involving defined segment sizes and locations.
A wide range of outcome measures were reported in the cohort studies. High levels of technical success or ability to place INTAC segments were reported. Technically related complications were often delayed and generally reported as segment migration attributable to early experience. Overall, complications were infrequently reported and largely involved minor reversible events without clinical sequelae.
The outcomes reported across studies involved statistically significant and clinically relevant improvements in corneal topography, refraction and visual acuity, for both uncorrected and best-corrected visual acuity. Patients’ vision was usually restored to within normal functioning levels and for those not achieving satisfactory correction, insertion of intraocular lenses was reported in case studies to result in additional gains in visual acuity. Vision loss (infrequently reported) was usually reversed by implant exchange or removal. The primary effects of INTACS on corneal surface remodelling were consistent with secondary improvements in refractive error and visual acuity. The improvements in visual acuity and refractive error noted at 6 months were maintained at 1 and 2-year follow-up
Improvements in visual acuity and refractive error following insertion of INTACS, however, were not noted for all patients. Although improvements were not found to vary across age groups there were differences across stages of disease. Several reports suggested that improvements in visual acuity and refractive outcomes may not be as large or predictable in more advanced stages of KC. Some studies have suggested that the effects of INTACs were much greater in flattening the corneal surface than in correcting astigmatism. However, these studies involved small numbers of high risk patients in advanced stages of KC and conclusions made from this group are limited.
INTACS were used for other indications other than primary KC. The results of implant insertion on corneal topography, refraction, and visual acuity in post-LASIK thinning cases were similar to those reported for KC. The evidence for this indication, however, only involved case reports and small case series. INTACS were also successfully used to treat recurrent KC after corneal transplant but this was based on only a single case report. Corneal implants were compared to corneal transplantation but these studies were not randomized and based on small numbers of selected patients.
The foremost limitation of the evidence base is the basic study design in the reports that involved longitudinal follow-up only for the treated group; there were no randomized trials. Follow-up in the trials (although at prescribed intervals) often had incomplete accounts of losses at follow-up and estimates of change were often not reported or based on group differences. Second, although standardized outcome measures were reported, contact lens tolerance (a key treatment objective) was infrequently specified. A third general limitation was the lack of reporting of patients’ satisfaction with their vision quality or functional vision. Outcome measures for vision quality and impact on patient quality of life were available but rarely reported and have been noted to be a limitation in ophthalmological literature in general. Fourth, the longitudinal cohort studies have not followed patients long enough to evaluate the impact of implants on the underlying disease process (follow-up beyond 3 years is limited). Additionally, only a few of these studies directly examined corneal thinning in follow-up. The overall quality of evidence determined using the GRADE hierarchy of evidence was moderate.
There is some evidence in these studies to support the claim that corneal implants do not interfere with, or increase the difficultly of, subsequent corneal transplant, at least for those performed shortly after INTAC placement. Although it’s uncertain for how long implants can delay the need for a corneal transplant, given that patients with KC are often young (in their twenties and thirties), delaying transplant for any number of years may still be a valuable consideration.
The clinical indications for corneal implants have evolved from management of myopia in normal eyes to the management of corneal thinning disorders such as KC and thinning occurring after refractive surgery. Despite the limited evidence base for corneal implants, which consists solely of longitudinal follow-up studies, they appear to be a valuable clinical tool for improving vision in patients with corneal thinning. For patients unable to achieve functional vision, corneal implants achieved statistically significant and clinically relevant improvements in corneal topography, refraction, and visual acuity, providing a useful alternative to corneal transplant. Implants may also have a rescue function, treating corneal thinning occurring after refractive surgery in normal eyes, or managing refractive errors following corneal transplant. The treatment offers several advantages in that it’s an outpatient based procedure, is associated with minimal risk, and has high technical success rates. Both eyes can be treated at once and the treatment is adjustable and reversible. The implants can be removed or exchanged to improve vision without limiting subsequent interventions, particularly corneal transplant.
Better reporting on vision quality, functional vision and patient satisfaction, however, would improve evaluation of the impact of these devices. Information on the durability of the implants’ treatment effects and their affects on underlying disease processes is limited. This information is becoming more important as alternative treatment strategies, such as collagen cross-linking aimed at strengthening the underlying corneal tissue, are emerging and which might prove to be more effective or increase the effectiveness of the implants, particularly in advances stages of corneal thinning.
Ontario Health System Considerations
At present there are approximately 70 ophthalmologists in Canada who’ve had training with corneal implants; 30 of these practice in Ontario. Industry currently sponsors the training, proctoring and support for the procedure. The cost of the implant device ranges from $950 to $1200 (CAD) and costs for instrumentation range from $20,000 to $30,000 (CAD) (a one time capital expenditure). There is no physician services fee code for corneal implants in Ontario but assuming that they are no higher than those for a corneal transplant, the estimated surgical costs would be $914.32(CAD) An estimated average cost per patient, based on device costs and surgical fees, for treatment is $1,964 (CAD) (range $1,814 to $2,114) per eye. There have also been no out of province treatment requests. In Ontario the treatment is currently being offered in private clinics and an increasing number of ophthalmologists are being certified in the technique by the manufacturer.
KC is a rare disease and not all of these patients would be eligible candidates for treatment with corneal implants. Based on published population rates of KC occurrence, it can be expected that there is a prevalent population of approximately 6,545 patients and an incident population of 240 newly diagnosed cases per year. Given this small number of potential cases, the use of corneal implants would not be expected to have much impact on the Ontario healthcare system. The potential impact on the provincial budget for managing the incident population, assuming the most conservative scenario (i.e., all are eligible and all receive bilateral implants) ranges from $923 thousand to $1.1 million (CAD). This estimate would vary based on a variety of criteria including eligibility, unilateral or bilateral interventions, re-interventions, capacity and uptake
Keratoconus, corneal implants, corneal topography, corneal transplant, visual acuity, refractive error
PMCID: PMC3385416  PMID: 23074513
6.  Treatment principles for osteochondral lesions in foot and ankle 
International Orthopaedics  2013;37(9):1697-1706.
Osteochondral lesion of the talus (OLT) is a broad term used to describe an injury or abnormality of the talar articular cartilage and adjacent bone. A variety of terms have been used to refer to this clinical entity, including osteochondritis dissecans (OCD), osteochondral fracture and osteochondral defect. Whether OLT is a precursor to more generalised arthrosis of the ankle remains unclear, but the condition is often symptomatic enough to warrant treatment. In more than one third of cases, conservative treatment is unsuccessful, and surgery is indicated. There is a wide variety of treatment strategies for osteochondral defects of the ankle, with new techniques that have substantially increased over the last decade. The common treatment strategies of symptomatic osteochondral lesions include nonsurgical treatment, with rest, cast immobilisation and use of nonsteroidal anti-inflammatory drugs (NSAIDs). Surgical options are lesion excision, excision and curettage, excision combined with curettage and microfracturing, filling the defect with autogenous cancellous bone graft, antegrade (transmalleolar) drilling, retrograde drilling, fixation and techniques such as osteochondral transplantation [osteochondral autograft transfer system (OATS)] and autologous chondrocyte implantation (ACI). Furthermore, smaller lesions are symptomatic and when left untreated, OCDs can progress; current treatment strategies have not solved this problem. The target of these treatment strategies is to relieve symptoms and improve function. Publications on the efficacy of these treatment strategies vary. In most cases, several treatment options are viable, and the choice of treatment is based on defect type and size and preferences of the treating clinician.
PMCID: PMC3764304  PMID: 23982639
Osteochondral lesions; Osteochondritis dissecans; Talus; Foot and ankle; Cartilage damage; Subchondral bone
7.  Arthroscopic intralesional curettage for large benign talar dome cysts 
SICOT-J  null;1:32.
Introduction: Surgical management of large talar dome cysts is challenging due to increased morbidity by associated cartilage damage and malleolar osteotomy. The purpose of this study is to evaluate the clinical and radiological outcome of endoscopic curettage and bone graft for large talar dome cysts.
Methods: This is a retrospective analysis of data for eight patients (eight feet) who were treated by arthroscopic curettage and grafting for large talar dome cysts. Seven cases were treated by posterior ankle arthroscopy as the lesion was located posteriorly while one case was treated by anterior ankle arthroscopy as the lesion was breached anteriorly.
Results: The final diagnosis, was; large osteochondral lesion of talus (two cases), aneurysmal bone cyst (ABC) (two case), intra-osseous ganglion (two cases), Chronic infection in talus (one case) and angiomatous lesion of the talus (one case). The mean follow up period was 18.3 (±3.06 SD) months (range 16–25 months). The median preoperative AOFAS score was 74.5 (±5.34 SD) points. The mean postoperative AOFAS score at one year follow up was 94.6 (±2.97 SD) points. None of the patient had recurrence of the lesion during follow up. Return to normal daily activity was achieved at 11.25 (±2.37 SD) weeks.
Discussion: In this short case series study, large talar dome bony cysts of different pathologies including aneurysmal bone cysts could be treated effectively by endoscopic curettage and bone grafting with no recurrence no complications during the follow-up period.
PMCID: PMC4849243  PMID: 27163087
Hindfoot endoscopy; Talar dome cysts; Aneurysmal bone cyst talus
8.  Effects of a contoured articular prosthetic device on tibiofemoral peak contact pressure: a biomechanical study 
Many middle-aged patients are affected by localized cartilage defects that are neither appropriate for primary, nor repeat biological repair methods, nor for conventional arthroplasty. This in vitro study aims to determine the peak contact pressure in the tibiofemoral joint with a partial femoral resurfacing device (HemiCAP®, Arthrosurface Inc., Franklin, MA, USA). Peak contact pressure was determined in eight fresh-frozen cadaveric specimens using a Tekscan sensor placed in the medial compartment above the menisci. A closed loop robotic knee simulator was used to test each knee in static stance positions (5°/15°/30°/45°) with body weight ground reaction force (GRF), 30° flexion with twice the body weight (2tBW) GRF and dynamic knee-bending cycles with body weight GRF. The ground reaction force was adjusted to the living body weight of the cadaver donor and maintained throughout all cycles. Each specimen was tested under four different conditions: Untreated, flush HemiCAP® implantation, 1-mm proud implantation and 20-mm defect. A paired sampled t test to compare means (significance, P ≤ 0.05) was used for statistical analysis. On average, no statistically significant differences were found in any testing condition comparing the normal knee with flush device implantation. With the 1-mm proud implant, statistically significant increase of peak contact pressures of 217% (5° stance), 99% (dynamic knee bending) and 90% (30° stance with 2tBW) compared to the untreated condition was seen. No significant increase of peak contact pressure was evaluated with the 20-mm defect. The data suggests that resurfacing with the HemiCAP® does not lead to increased peak contact pressure with flush implantation. However, elevated implantation results in increased peak contact pressure and might be biomechanically disadvantageous in an in vivo application.
PMCID: PMC2190783  PMID: 17934718
Osteochondral defect; Tibiofemoral joint; Articular prosthetic device; Peak contact pressure; Knee biomechanics
9.  Diagnosing, planning and evaluating osteochondral ankle defects with imaging modalities 
World Journal of Orthopedics  2015;6(11):944-953.
This current concepts review outlines the role of different imaging modalities in the diagnosis, preoperative planning, and follow-up of osteochondral ankle defects. An osteochondral ankle defect involves the articular cartilage and subchondral bone (usually of the talus) and is mostly caused by an ankle supination trauma. Conventional radiographs are useful as an initial imaging tool in the diagnostic process, but have only moderate sensitivity for the detection of osteochondral defects. Computed tomography (CT) and magnetic resonance imaging (MRI) are more accurate imaging modalities. Recently, ultrasonography and single photon emission CT have been described for the evaluation of osteochondral talar defects. CT is the most valuable modality for assessing the exact location and size of bony lesions. Cartilage and subchondral bone damage can be visualized using MRI, but the defect size tends to be overestimated due to bone edema. CT with the ankle in full plantar flexion has been shown a reliable tool for preoperative planning of the surgical approach. Postoperative imaging is useful for objective assessment of repair tissue or degenerative changes of the ankle joint. Plain radiography, CT and MRI have been used in outcome studies, and different scoring systems are available.
PMCID: PMC4686441  PMID: 26716090
Cartilage; Subchondral bone; Imaging; Ankle; Talus; Radiography; Computed tomography; Magnetic resonance imaging; Outcome assessment
10.  Ankle Morphometry on 3D-CT Images 
Understanding three-dimensional (3D) morphology of the ankle is essential for a better total ankle replacement. Current designs neither mimic the articular geometry at the bearing surface interfaces nor match the native bony bed with the implant's external dimensions. This is likely due to insufficient anthropometric data on sizing and geometry. We performed this study to determine the range of possible sizes of ankle joints based on high-resolution 3D-CT images. Clinical 3D-CT images from twenty-one normal ankles (11 males, 10 females) were subjected to morphometric evaluation. A local coordinate system for measurement was established based on talar anatomic landmarks. Measurements included the width of the superior talar dome surface (measured at the anterior, middle, and posterior portions) and the arc radius of the talar dome. The results yielded an average anterior width of 29.9 ± 2.6 mm, a middle width of 27.9 ± 3.0 mm, and a posterior width of 25.2 ± 3.7 mm. The talar dome radius was 20.7 ± 2.6 mm. The width linearly decreased from anterior to posterior (p < 0.001). A significant gender difference was found in both the width and the radius (p-values < 0.05), except at the middle width (p = 0.07). The data describe talar topography in a Caucasian U.S. adult cohort, suggesting the capability of the 3D-CT approach for ankle morphometric evaluation and sizing for the fabrication of total ankle replacements.
PMCID: PMC1888582  PMID: 16789441
11.  Additional mesenchymal stem cell injection improves the outcomes of marrow stimulation combined with supramalleolar osteotomy in varus ankle osteoarthritis: short-term clinical results with second-look arthroscopic evaluation 
Supramalleolar osteotomy (SMO) is reported to be an effective treatment for varus ankle osteoarthritis by redistributing the load line within the ankle joint. Mesenchymal stem cells (MSCs) have been proposed as a new treatment option for osteoarthritis on the basis of their cartilage regeneration ability. The purpose of this study was to compare the clinical, radiological, and second-look arthroscopic outcomes between MSC injection with marrow stimulation and marrow stimulation alone in patients with varus ankle osteoarthritis who have undergone SMO.
In this retrospective study, 62 patients (64 ankles) with varus ankle osteoarthritis underwent second-look arthroscopy at a mean of 12.8 months after arthroscopic marrow stimulation combined with SMO; 33 ankles were subjected to marrow stimulation alone (group I), and 31 were subjected to marrow stimulation with MSC injection (group II). Clinical outcome measures included a visual analog scale (VAS) for pain and the American Orthopaedic Foot and Ankle Society (AOFAS) score. Radiological outcome variables included the tibial–ankle surface (TAS), talar tilt (TT), and tibial–lateral surface (TLS) angles. In second-look arthroscopy, cartilage regeneration was evaluated using the International Cartilage Repair Society (ICRS) grade.
The mean VAS score improved significantly from 7.2 ± 1.0 to 4.7 ± 1.4 in group I and from 7.3 ± 0.8 to 3.7 ± 1.5 in group II at the final follow-up (P < 0.001 for both groups). The mean AOFAS score also improved significantly from 61.7 ± 5.8 to 80.9 ± 6.7 in group I and from 60.6 ± 6.1 to 85.2 ± 5.1 in group II at the final follow-up (P < 0.001 for both groups). There were significant differences in the mean VAS and AOFAS scores between groups at the final follow-up (P = 0.002 and 0.010, respectively). At second-look arthroscopy, there were significant differences in ICRS grades between groups(P = 0.015 for medial aspect of the talar dome, P = 0.044 for medial aspect of the tibial plafond, and P = 0.005 for articular surface of the medial malleolus). ICRS grades were significantly correlated with clinical outcomes in both groups (all P < 0.05). Mean TAS, TT, and TLS angles improved significantly after SMO in both groups but were not significantly correlated with clinical outcomes or ICRS grade (all n.s.).
The clinical and second-look arthroscopic outcomes of MSC injection with marrow stimulation were better compared to those of marrow stimulation alone in patients with varus ankle osteoarthritis who have undergone SMO. Furthermore, the ICRS grade is significantly correlated with clinical outcome.
PMCID: PMC4875581  PMID: 27206975
Mesenchymal stem cell; Marrow stimulation; Supramalleolar osteotomy; Varus ankle osteoarthritis
12.  One-step Bone Marrow-derived Cell Transplantation in Talar Osteochondral Lesions 
The ideal treatment of osteochondral lesions is debatable. Although autologous chondrocyte implantation provides pain relief, the need for two operations and high costs has prompted a search for alternatives. Bone marrow-derived cells may represent the future in osteochondral repair. Using a device to concentrate bone marrow-derived cells and collagen powder or hyaluronic acid membrane as scaffolds for cell support and platelet gel, a one-step arthroscopic technique was developed for cartilage repair. We performed an in vitro preclinical study to verify the capability of bone marrow-derived cells to differentiate into chondrogenic and osteogenic lineages and to be supported onto scaffolds. In a prospective clinical study, we investigated the ability of this technique to repair talar osteochondral lesions in 48 patients. Minimum followup was 24 months (mean, 29 months; range, 24–35 months). Clinical results were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) score and the influence of scaffold type, lesion area, previous surgeries, and lesion depth was considered. MRI and histologic evaluation were performed. The AOFAS score improved from 64.4 ± 14.5 to 91.4 ± 7.7. Histologic evaluation showed regenerated tissue in various degrees of remodeling although none showed entirely hyaline cartilage. These data suggest the one-step technique is an alternative for cartilage repair, permitting improved functional scores and overcoming the drawbacks of previous techniques.
Level of Evidence: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
PMCID: PMC2772930  PMID: 19449082
13.  Assessment of Ankle and Hindfoot Stability and Joint Pressures Using a Human Cadaveric Model of a Large Lateral Talar Process Excision 
Medicine  2015;94(11):e606.
Lateral talar process fragment excision may be followed by hindfoot instability and altered biomechanics. There is controversy regarding the ideal fragment size for internal fixation versus excision and a concern that excision of a large fragment may lead to significant instability. The aim of this study was to assess the effect of a simulated large lateral talar process excision on ankle and subtalar joint stability.
A custom-made seesaw rig was designed to apply inversion/eversion stress loading on 7 fresh-frozen human cadaveric lower legs and investigate them in pre-excision, 5 cm3 and 10 cm3 lateral talar process fragment excision states. Anteroposterior radiographs were taken to assess ankle and subtalar joint tilt and calculate angular change from neutral hindfoot alignment to 10-kg forced inversion/eversion. Ankle joint pressures and contact areas were measured under 30-kg axial load in neutral hindfoot alignment.
In comparison to the pre-excision state, no significantly different mediolateral angular change was observed in the subtalar joint after 5 and 10 cm3 lateral talar process fragment excision in inversion and eversion. With respect to the ankle joint, 10-cm3 fragment excision produced significantly bigger inversion tibiotalar tilt compared with the pre-excision state, P = .04. No significant change of the ankle joint pressure and contact area was detected after 5 and 10-cm3 excision in comparison with the pre-excison state.
An excision of up to 10 cm3 of the lateral talar process does not cause a significant instability at the level of the subtalar joint but might be a destabilizing factor at the ankle joint under inversion stress. The latter could be related to extensive soft tissue dissection required for resection.
PMCID: PMC4602496  PMID: 25789950
14.  Bone Microarchitecture of the Talus Changes With Aging 
Fractures of the talus in the elderly are rare and usually result from high-impact injuries, suggesting only minor age-related bone structure changes. However, total ankle replacement failures with age often result from talar subsidence, suggesting age-related bone loss in the talus. Despite a number of histological analyses of talar microarchitecture, the effects of age and sex on talar microarchitecture changes remain poorly defined.
The aim of this study was to analyze changes or differences in the trabecular microarchitecture of the talus with regard to (1) age and (2) sex.
Sixty human tali were harvested from 30 patients at autopsy of three different age groups (20–40, 41–60, 61–80 years). The specimens were analyzed by radiography, micro-CT, and histological analysis. Given that there was no difference between the left and right talus, static histomorphometric parameters were assessed in three regions of interest of the right talus only (body, neck, head; n = 30).
The talar body, neck, and head were affected differently by age-related changes. The greatest loss of bone volume with age was seen in the talar body (estimate: −0.239; 95% confidence interval [CI], −0.365 to −0.114; p < 0.001). In the talar neck (estimate: −0.165; 95% CI, −0.307 to −0.023; p = 0.025), bone loss was only moderate and primarily was the result of reduction in trabecular thickness (estimate: −1.288; 95% CI, −2.449 to −0.127; p = 0.031) instead of number (estimate: −0.001; 95% CI, −0.005 to −0.003; p = 0.593). Bone structure changes were independent of sex.
Age-related bone structure changes predominantly occur in the talar body, which poses a potential risk factor for total ankle replacement loosening. The moderate changes in the talar neck might explain the persistent low incidence of talar neck fractures with age.
Clinical Relevance
Our findings suggest that before total ankle replacement implantation, careful patient selection with dual-energy xray absorptiometry evaluation may be necessary to reduce the risk of talar implant subsidence.
PMCID: PMC3792264  PMID: 23893363
15.  Cartilage repair techniques of the talus: An update 
World Journal of Orthopedics  2014;5(3):171-179.
Symptomatic chondral or osteochondral defects of the talus reduce the quality of life of many patients. Although their pathomechanism is well understood, it is well known that different aetiologic factors play a role in their origin. Additionally, it is well recognised that the talar articular cartilage strongly differs from that in the knee. Despite this fact, many recommendations for the management of talar cartilage defects are based on approaches that were developed for the knee. Conservative treatment seems to work best in paediatric and adolescent patients with osteochondritis dissecans. However, depending on the size of the lesions, surgical approaches are necessary to treat many of these defects. Bone marrow stimulation techniques may achieve good results in small lesions. Large lesions may be treated by open procedures such as osteochondral autograft transfer or allograft transplantation. Autologous chondrocyte transplantation, as a restorative procedure, is well investigated in the knee and has been applied in the talus with increasing popularity and promising results but the evidence to date is poor. The goals of the current article are to summarise the different options for treating chondral and osteochondral defects of the talus and review the available literature.
PMCID: PMC4095009  PMID: 25035819
Cartilage defect; Talus; Repair techniques; Arthroscopy; Marrow stimulation; Mosaicplasty; Autologous chondrocyte implantation
16.  Matrix-Associated and Autologous Chondrocyte Transplantation in the Ankle 
Cartilage  2011;2(1):81-91.
New matrix-associated autologous chondrocyte transplantation (MACT) techniques may facilitate the treatment of chondral defects in talar cartilage and provide good clinical outcome in the long term. The aim of this prospective case series was to monitor the clinical outcome after autologous chondrocyte transplantation (ACT) and MACT in the ankle to gain data on the mid-term efficacy of the procedure.
Seventeen cases of talar cartilage defects were assessed with the American Orthopaedic Foot and Ankle Score (AOFAS), a modified Cincinnati score, and a subjective ankle-hindfoot score (AHS) at a mean of 61 (24-135) months after surgery. Nine patients consented to an additional magnetic resonance imaging (MRI) exam, including T2 mapping at 3T. ACT was carried out with a periosteal flap (4 cases) or with a matrix-assisted ACT technique (Hyalograft C; 13 cases).
Significant improvement was found in all cases. The AOFAS improved from 50.0 to 87.3, the AHS from 43.8 to 84.1, and the modified Cincinnati score from 2.9 to 6.9. MRI data demonstrated good defect filling, and T2 mapping results indicated that the collagen and water content of the repair tissue was comparable to adjacent cartilage.
MACT and ACT in the ankle can provide good and excellent long-term outcome and resulted in repair tissue with T2 properties similar to native cartilage in the majority of cases. Matrix-assisted implantation with the hyaluronan matrix allows for a less invasive surgical procedure.
Level of evidence:
4; prospective case series study.
PMCID: PMC4300785  PMID: 26069572
ACI; autologous chondrocyte transplantation; ankle; cartilage repair; T2 mapping; 3T
17.  Improved Visualization of the 70° Arthroscope in the Treatment of Talar Osteochondral Defects 
Arthroscopy Techniques  2013;2(2):e129-e133.
Osteochondral defects (OCDs) of the talus are a common cause of residual pain after ankle injuries. When conservative treatment fails, arthroscopic debridement combined with drilling/microfracturing of the lesion (bone marrow stimulation [BMS] procedures) has been shown to provide good to excellent outcomes. Not uncommonly, talar OCDs involve the borders of the talar dome. These uncontained lesions are sometimes difficult to visualize with the 30° arthroscope, with potential negative effect on the clinical outcome of an arthroscopic BMS procedure. The use of the 70° arthroscope has been described for a multitude of common knee, shoulder, elbow, and hip procedures. The purpose of this article is to show the usefulness of the 70° arthroscope in arthroscopic BMS procedures, pointing out which kinds of talar OCDs can benefit most from its use.
PMCID: PMC3716212  PMID: 23875138
18.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
19.  Radiographic Predictability of Cartilage Damage in Medial Ankle Osteoarthritis 
Radiographic grading has been used to assess and select between treatment options for ankle osteoarthritis. To use radiographic grading systems in clinical practice and scientific studies one must have reliable systems that predict the fate of the cartilage.
We therefore asked whether (1) radiographic grading of ankle osteoarthritis is reliable and (2) grading reflects cartilage damage observed during arthroscopy. We then (3) determined the sensitivity, specificity, and predictive values of the radiographic findings.
Patients and Methods
We examined 74 ankles with medial osteoarthritis and 24 with normal articular cartilage based on arthroscopy. Arthroscopic findings were graded according to the modified Outerbridge grades and all radiographs were graded using the modified Kellgren-Lawrence, Takakura et al., and van Dijk et al. grading systems. The reliability of each radiographic grading system was evaluated. We correlated the radiographic grades and severity of cartilage damage for each radiographic grading system. Sensitivity, specificity, and predictive values of spurs and joint space narrowing with or without talar tilting then were determined.
The interobserver weighted kappa ranged from 0.58 to 0.89 and the intraobserver weighted kappa from 0.51 to 0.85. The correlation coefficients for the Kellgren-Lawrence, Takakura et al., and van Dijk et al. grades were 0.53, 0.42, and 0.42, respectively. Ankles with medial joint space narrowing (Stage 2 of Takakura et al. and van Dijk et al. grades) showed varying severity of cartilage damage. The positive predictive value of cartilage damage increased from 77% for medial joint space narrowing regardless of the presence of talar tilting to 98% for medial joint space narrowing with talar tilting.
Our observations suggest the inclusion of talar tilting in grading schemes enhances the assessment of cartilage damage.
Level of Evidence
Level II, diagnostic study. See the Guidelines for Authors for a complete description of level of evidence.
PMCID: PMC2895860  PMID: 20393817
20.  One-step bone marrow-derived cell transplantation in talarosteochondral lesions: mid-term results 
Joints  2014;1(3):102-107.
to verify the capability of scaffold-supported bone marrow-derived cells to be used in the repair of osteochondral lesions of the talus.
using a device to concentrate bone marrow-derived cells, a scaffold (collagen powder or hyaluronic acid membrane) for cell support and platelet gel, a one-step arthroscopic technique was developed for cartilage repair. In a prospective clinical study, we investigated the ability of this technique to repair talar osteochondral lesions in 64 patients. The mean follow-up was 53 months. Clinical results were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) scale score. We also considered the influence of scaffold type, lesion area, previous surgery, and lesion depth.
the mean preoperative AOFAS scale score was 65.2 ± 13.9. The clinical results peaked at 24 months, before declining gradually to settle at a score of around 80 at the maximum follow-up of 72 months.
the use of bone marrow-derived cells supported by scaffolds to repair osteochondral lesions of the talus resulted in significant clinical improvement, which was maintained over time.
Level of Evidence
level IV, therapeutic case series.
PMCID: PMC4295704  PMID: 25606518
bone marrow-derived cells; cartilage; osteochondral defect; repair; talus
21.  Osteochondritis Dissecans of the Talar Dome in a Collegiate Swimmer: A Case Report 
Journal of Athletic Training  1998;33(4):365-371.
To present the case of an intercollegiate swimmer with a stage IV lateral talar dome injury and associated bony fragments.
Lack of distinct diagnostic symptoms, low index of clinical suspicion, and the difficulty of visualizing the early stages of this injury on standard x-rays cause frequent misdiagnosis of talar dome lesions.
Differential Diagnosis:
Ganglion cyst, with inflammatory synovitis secondary to rupture of cyst; loose bodies from previous occult fracture; osteochondral fracture.
Initial treatment with nonsteroidal antiinflammatory drugs and a posterior splint for comfort, followed by arthroscopic excision of loose bodies with abrasion and drilling arthroplasty.
Patient presented to the team physician for care of acute left medial ankle pain after the athletic trainer had attempted to rupture a ganglion cyst on the anterolateral aspect of the patient's ankle.
Increased clinical suspicion is necessary to correctly diagnose osteochondral lesions, particularly in the early stages. Aggressive treatment of talar dome lesions has a good success rate and may be an attractive option for competitive athletes.
PMCID: PMC1320590  PMID: 16558537
ganglion cyst; inflammatory synovitis; osteochondral fracture
22.  The use of fibrin matrix-mixed gel-type autologous chondrocyte implantation in the treatment for osteochondral lesions of the talus 
This study assessed the clinical results and second-look arthroscopy after fibrin matrix-mixed gel-type autologous chondrocyte implantation to treat osteochondral lesions of the talus.
Chondrocytes were harvested from the cuboid surface of the calcaneus in 38 patients and cultured, and gel-type autologous chondrocyte implantation was performed with or without medial malleolar osteotomy. Preoperative American orthopedic foot and ankle society ankle-hind foot scores, visual analogue score, Hannover scoring system and subjective satisfaction were investigated, and the comparison of arthroscopic results (36/38, 94.7 %) and MRI investigation of chondral recovery was performed. Direct tenderness and relationship to the active daily life of the donor site was evaluated.
The preoperative mean ankle–hind foot scores (71 ± 14) and Hannover scoring system (65 ± 10) had increased to 91 ± 12 and 93 ± 14, respectively, at 24-month follow-up (p < 0.0001), and the preoperative visual analogue score of 58 mm had decreased to 21 mm (p < 0.0001). Regarding subjective satisfaction, 34 cases (89.5 %) reported excellent, good or fair. Chondral regeneration was analysed by second-look arthroscopy and MRI. Complications included one non-union and two delayed-unions of the osteotomy sites, and 9 ankles (9/31, 29.0 %) sustained damaged medial malleolar cartilage due to osteotomy. Marked symptoms at the biopsy site did not adversely affect the patient’s active daily life.
Fibrin matrix-mixed gel-type autologous chondrocyte implantation using the cuboid surface of the calcaneus as a donor can be used for treating osteochondral lesions of the talus.
Level of evidence
Therapeutic study, prospective case series, Level IV.
PMCID: PMC3657090  PMID: 22752415
Talus; Osteochondral lesion; Autologous chondrocyte implantation; Arthroscopy; Donor
23.  A Novel System Improves Preservation of Osteochondral Allografts 
Osteochondral allografting is an option for successful treatment of large articular cartilage defects. Use of osteochondral allografting is limited by graft availability, often because of loss of chondrocyte viability during storage.
The purpose of this study was to compare osteochondral allografts implanted in canine knees after 28 days or 60 days of storage for (1) initial (1 week) safety and feasibility; (2) integrity and positioning with time (12 weeks and 6 months); and (3) gross, cell viability, histologic, biochemical, and biomechanical characteristics at an endpoint of 6 months.
With Institutional Animal Care and Use Committee approval, adult dogs (n = 16) were implanted with 8-mm cylindrical osteochondral allografts in the lateral and medial femoral condyles of one knee. Osteochondral allografts preserved for 28 or 60 days using either the current tissue bank standard-of-care (SOC) or a novel system (The Missouri Osteochondral Allograft Preservation System, or MOPS) were used, creating four treatment groups: SOC 28-day, MOPS 28-day, SOC 60-day, and MOPS 60-day. Bacteriologic analysis of tissue culture and media were performed. Dogs were assessed by radiographs and arthroscopy at interim times and by gross, cell viability, histology, biochemistry, and biomechanical testing at the 6-month endpoint.
With the numbers available, there was no difference in infection frequency during storage (5% for SOC and 3% for MOPS; p = 0.5). No infected graft was implanted and no infections occurred in vivo. MOPS grafts had greater chondrocyte viability at Day 60 (90% versus 53%; p = 0.002). For 60-day storage, MOPS grafts were as good as or better than SOC grafts with respect to all outcome measures assessed 6 months after implantation.
Donor chondrocyte viability is important for osteochondral allograft success. MOPS allows preservation of chondrocyte viability for up to 60 days at sufficient levels to result in successful outcomes in a canine model of large femoral condylar articular defects.
Clinical Relevance
These findings provide a promising development in osteochondral allograft technology that can benefit the quantity of grafts available for use and the quality of grafts being implanted.
PMCID: PMC4182376  PMID: 25030100
24.  Differences in joint morphology between the knee and ankle affect the repair of osteochondral defects in a rabbit model 
Although differences in the results of the bone marrow stimulation technique between the knee and ankle have been reported, a detailed mechanism for those differences has not been clarified. The purpose of this study was to examine whether morphological differences between the knee and ankle joint affect the results of drilling as treatment for osteochondral defects in a rabbit model.
Osteochondral defects were created at the knee and ankle joint in the rabbit. In the knee, osteochondral defects were created at the medial femoral condyle (MFC) and patellar groove (PG). At the ankle, defects were created in the talus at either a covered or uncovered area by the tibial plafond. After creating the osteochondral defect, drilling was performed. At 4, 8, and 12 weeks after surgery, repair of the osteochondral defects were evaluated histologically. The proliferation of rabbit chondrocytes and proteoglycan release of cartilage tissue in response to IL-1β were analyzed in vitro in both joints.
At 8 weeks after surgery, hyaline cartilage repair was observed in defects at the covered area of the talus and the MFC. At 12 weeks, hyaline cartilage with a normal thickness was observed for the defect at the covered area of the talus, but not for the defect at the MFC. At 12 weeks, subchondral bone formation progressed and a normal contour of subchondral bone was observed on CT in the defect at the covered area of the talus. No significant differences in chondrocyte proliferation rate and proteoglycan release were detected between the knee and ankle in vitro.
Our results demonstrate that the covered areas of the talus show early and sufficient osteochondral repair compared to that of the knee and the uncovered areas of the talus. These results suggest that the congruent joint shows better subchondral repair prior to cartilage repair compared to that of the incongruent joint.
PMCID: PMC5050570  PMID: 27716360
Ankle; Knee; Congruency; Subchondral bone; Rabbit
25.  No Effect of Hole Geometry in Microfracture for Talar Osteochondral Defects 
Débridement and bone marrow stimulation is an effective treatment option for patients with talar osteochondral defects. However, whether surgical factors affect the success of microfracture treatment of talar osteochondral defects is not well characterized.
We hypothesized (1) holes that reach deeper into the bone marrow-filled trabecular bone allow for more hyaline-like repair; and (2) a larger number of holes with a smaller diameter result in more solid integration of the repair tissue, less need for new bone formation, and higher fill of the defect.
Talar osteochondral defects that were 6 mm in diameter were drilled bilaterally in 16 goats (32 samples). In eight goats, one defect was treated by drilling six 0.45-mm diameter holes in the defect 2 mm deep; in the remaining eight goats, six 0.45-mm diameter holes were punctured to a depth of 4 mm. All contralateral defects were treated with three 1.1-mm diameter holes 3 mm deep, mimicking the clinical situation, as internal controls. After 24 weeks, histologic analyses were performed using Masson-Goldner/Safranin-O sections scored using a modified O’Driscoll histologic score (scale, 0–22) and analyzed for osteoid deposition. Before histology, repair tissue quality and defect fill were assessed by calculating the mean attenuation repair/healthy cartilage ratio on Equilibrium Partitioning of an Ionic Contrast agent (EPIC) micro-CT (μCT) scans. Differences were analyzed by paired comparison and Mann-Whitney U tests.
Significant differences were not present between the 2-mm and 4-mm deep hole groups for the median O’Driscoll score (p = 0.31) and the median of the μCT attenuation repair/healthy cartilage ratios (p = 0.61), nor between the 0.45-mm diameter and the 1.1-mm diameter holes in defect fill (p = 0.33), osteoid (p = 0.89), or structural integrity (p = 0.80).
The results indicate that the geometry of microfracture holes does not influence cartilage healing in the caprine talus.
Clinical Relevance
Bone marrow stimulation technique does not appear to be improved by changing the depth or diameter of the holes.
PMCID: PMC3792274  PMID: 23893362

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