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1.  Is Pain and Dissatisfaction After TKA Related to Early-grade Preoperative Osteoarthritis? 
Background
There is growing evidence to suggest many patients experience pain and dissatisfaction after TKA. The relationship between preoperative osteoarthritis (OA) severity and postoperative pain and dissatisfaction after TKA has not been established.
Questions/Purposes
We explored the relationship between early-grade preoperative OA with pain and dissatisfaction after TKA by (1) determining the incidence of early-grade preoperative OA in painful TKAs with no other identifiable abnormality; and (2) comparing this incidence with the incidence of early-grade OA in three other cohorts of patients undergoing TKA.
Methods
We evaluated all (n = 49) painful TKAs in a 1-year period that had no evidence of loosening, instability, malalignment, infection, or extensor mechanism dysfunction and classified the degree of preoperative OA according to the scale of Kellgren and Lawrence. For comparison, we identified three other cohorts of TKAs from the same center and classified their preoperative grade of OA: Group B (n = 100) was a consecutive series of primary TKAs performed for OA during the same year; Group C (n = 80) were asymptomatic TKAs from 1 to 4 years postoperatively; and Group D (n = 80) were TKAs with some degree of pain at 1 to 4 years postoperatively.
Results
Patients in Group A had a higher incidence of early-grade OA is preoperatively (49%) compared with any of the comparison groups: Group B, 5%; Group C, 6%; and Group D, 10%.
Conclusions
A high percentage of patients referred for unexplained pain after TKA had early-grade osteoarthritis preoperatively. Patients undergoing TKA for less than Grade 3 or 4 OA should be informed that they may be at higher risk for persistent pain and dissatisfaction.
Level of Evidence
Level III, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-012-2465-6
PMCID: PMC3528890  PMID: 22923158
2.  Computer-assisted Total Knee Arthroplasty Is Currently of No Proven Clinical Benefit: A Systematic Review 
Background
Navigated total knee arthroplasty (TKA) may improve coronal alignment outliers; however, it is unclear whether navigated TKA improves the long-term clinical results of TKA.
Questions/Purposes
Does the literature contain evidence of better long-term function and lower revision rates with navigated TKA compared with conventional TKA?
Methods
A systematic literature review was conducted of navigated TKA reviewing articles related to coronal alignment, clinical knee and function scores, cost, patient satisfaction, component rotation, anteroposterior and mediolateral stability, complications, and longer-term reports.
Results
Coronal plane alignment is improved with navigated TKA with fewer radiographic outliers. We found limited evidence of improvements in any other variable, and function was not improved. The duration of surgery is increased and there are unique complications related to navigated TKA. The long-term benefits of additional increase in accuracy of alignment are not supported by any current evidence.
Conclusions
The findings in reports of navigated TKA should be interpreted with caution. There are few short- and medium- and no long-term studies demonstrating improved clinical outcomes using navigated TKA. Despite substantial research, contradictory findings coupled with reservations about the cost and efficacy of the technology have contributed to the failure of computer navigation to become the accepted standard in TKA. Longer-term studies demonstrating improved function, lower revision rates, and acceptable costs are required before navigated TKA may be widely adopted. In the future, with improvements in study design, methodology, imaging, navigation technology, newer functional outcome tools, and longer-term followup studies, we suspect that navigated TKA may demonstrate yet unrecognized benefits.
doi:10.1007/s11999-012-2528-8
PMCID: PMC3528921  PMID: 22948522
3.  Does Standing Affect Acetabular Component Inclination and Version After THA? 
Background
Avoiding complications after hip arthroplasty with hard-on-hard bearings, especially metal-on-metal, correlates with the position of the acetabular component. Supine imaging with conventional radiography has traditionally been utilized to assess component inclination (abduction), as well as anteversion, after THA and surface replacement arthroplasty (SRA). However, most adverse events with hard bearings (excessive wear and squeaking) have occurred with loading. Standing imaging, therefore, should provide more appropriate measurements.
Questions/purposes
We determined whether standing changed standard measurements of acetabular component position using a novel biplanar imaging system compared to traditional supine imaging.
Methods
We performed simultaneous biplanar standing imaging of the lower extremity with a novel imaging system using low radiation collimated beam on 46 patients who underwent THA (23) or SRA (23). Patients who had previously undergone THA had standard CT scans performed. For patients who underwent SRA, we compared acetabular inclination in the supine versus double-limb and single-limb standing.
Results
Standing anteversion differed from supine anteversion by greater than 5° for 12 of 23 patients who underwent THA (range, 5°–16°). For patients who underwent SRA, 13 of 23 patients exhibited a difference of greater than 3° in inclination between supine and double-limb standing images, and six of 23 patients exhibited a difference of greater than 3° in inclination between supine and single-limb standing images.
Conclusions
Standing changed the acetabular inclination and version in a substantial percentage of patients undergoing hip arthroplasty.
doi:10.1007/s11999-012-2391-7
PMCID: PMC3462863  PMID: 22610527
5.  Are Patient-specific Cutting Blocks Cost-effective for Total Knee Arthroplasty? 
Background
Using patient-specific cutting blocks for TKA increases the cost to the hospital for these procedures, but it has been proposed they may reduce operative times and improve implant alignment, which could reduce the need for revision surgery.
Questions/purposes
We compared TKAs performed with patient-specific cutting blocks with those performed with traditional instrumentation to determine whether there was improved operating room time management and component coronal alignment to support use of this technology.
Methods
We retrospectively reviewed 57 patients undergoing primary TKAs using patient-specific custom cutting blocks for osteoarthritis and compared them with 57 matched patients undergoing TKAs with traditional instrumentation during the same period (January 2009 to September 2010). At baseline, the groups were comparable with respect to age, sex, and BMI. We collected data on operative time (total in-room time and tourniquet time) and measured component alignment on plain radiographs.
Results
On average, TKAs performed with patient-specific instrumentation had similar tourniquet times (61.0 versus 56.2 minutes) but patients were in the operating room 12.1 minutes less (137.2 versus 125.1 minutes) than those in the standard instrumentation group. We observed no difference in the femorotibial angle in the coronal plane between the two groups.
Conclusions
Patient-specific instrumentation for TKA shows slight improvement in operating room time management but none in component alignment postoperatively. Therefore, routine use of this new technology may not be cost-effective in its current form.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-011-2221-3
PMCID: PMC3270159  PMID: 22183476
6.  Do Patient-specific Guides Improve Coronal Alignment in Total Knee Arthroplasty? 
Background
Coronal alignment may impact clinical outcome and survivorship in TKA. Patient-specific instrumentation has been developed to restore mechanical or kinematic axis and potentially reduce component malpositioning. Although it is clear these instruments add cost, it is unclear whether they improve alignment.
Questions/purposes
We determined whether the mean coronal alignment after TKA performed with conventional versus patient-specific instrumentation better restored the mechanical and kinematic axes and whether there were more outliers with one of the two methods.
Methods
We retrospectively evaluated 150 primary TKAs performed for osteoarthritis: Group 1 (n = 50) conventional instrumentation; Group 2 (n = 50) patient-specific instrumentation restoring the mechanical axis; Group 3 (n = 50) patient-specific instrumentation restoring the kinematic axis, and measured femorotibial angle, hip-knee-ankle angle, and the zone of the mechanical axis from scout CT images taken 0 to 6 weeks postoperatively.
Results
The mean femorotibial angle differed between the groups: Group 1 had the greatest varus mean alignment and most varus outliers. The mean hip-knee angle was similar between Groups 1 and 2, with Group 3 having greater valgus mean alignment and the most valgus outliers. For the zone of the mechanical axis, Groups 1 and 2 had similar percentages of outliers (40% versus 32%), whereas Group 3 had a greater number of outliers (64%) that were valgus.
Conclusions
TKAs with patient-specific instrumentation restoring the mechanical axis had a similar number of outliers as conventional instrumentation with both groups having more varus outliers than TKAs with patient-specific instrumentation restoring kinematic axis, which had more valgus outliers. Therefore, additional studies are needed to determine whether patient-specific instrumentation improves clinical function or patient satisfaction and whether their routine use can be justified in primary TKA.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-011-2222-2
PMCID: PMC3270188  PMID: 22183477
7.  Causes of Failure of Ceramic-on-Ceramic and Metal-on-Metal Hip Arthroplasties 
Background
Few large series of hard bearing surfaces have reported on reasons for early failure. A number of unique mechanisms of failure, including fracture, squeaking, and adverse tissue reactions, have been reported with these hard bearing surfaces. However, the incidence varies among the published studies.
Questions/purposes
To confirm the incidences, we identified the etiologies of early failures of hard-on-hard bearing surfaces for ceramic-on-ceramic and metal-on-metal THAs.
Methods
We retrospectively reviewed records of 2907 THAs with hard-on-hard bearing surfaces implanted between 1996 and 2009; 1697 (58%) had ceramic-on-ceramic and 1210 (42%) had metal-on-metal bearing surfaces. We recorded bearing-related complications and compared them to nonspecific reasons for revision THA. The minimum followup of the ceramic-on-ceramic and metal-on-metal cohorts was 6 months (mean, 48 months; range, 6–97 months) and 24 months (mean, 60 months; range, 24–178 months), respectively.
Results
The overall revision rate for ceramic-on-ceramic THA was 2.2% (38 of 1697), with aseptic loosening accounting for 55% of revisions (femur or acetabulum). The bearing accounted for 13% of the revisions in the ceramic-on-ceramic THA cohort. The overall metal-on-metal revision rate was 5.4% (65 of 1210), 17 involving adverse tissue reactions related to the metal-on-metal bearing surface (17 of 1210, 1.4% of cases; 17 of 65, 26% of revisions).
Conclusions
Twenty-six percent of the revisions from metal-on-metal and 13% of ceramic-on ceramic were bearing related. The overall short- to medium-term revision rate was 2.2% and 5.4% for ceramic-on-ceramic and metal-on-metal, respectively. The most common etiology of failure was loosening of the femoral or acetabular components.
Level of Evidence
Level IV, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.
doi:10.1007/s11999-011-2161-y
PMCID: PMC3254760  PMID: 22045071
8.  2011 Marshall Urist Young Investigator Award: When to Release Patients to High-impact Activities after Hip Resurfacing 
Background
Surface replacement arthroplasties are commonly performed in young, active patients who desire return to high-impact activities including heavy manual labor and recreational sports. Femoral neck fracture is an arthroplasty-related complication unique to surface replacement arthroplasty. However, it is unclear regarding whether patients are at lower risk for fracture after a certain postoperative time.
Questions/purposes
We therefore raised the following questions: (1) does stress shielding occur after surface replacement arthroplasty, and (2) when does bone mineral density return to normal so patients can return to high-impact activities without excessive risk of fracture?
Patients and Methods
We prospectively enrolled 90 patients (96 hips) with either surface replacement arthroplasty or THA, and performed dual energy x-ray absorptiometry scans at 6 weeks, 6 months, 1 year, and 2 years. We analyzed bone density by Gruen zone in both groups, and six femoral neck zones in the patients who had surface replacement arthroplasties. We calculated 6-month, 1-year, and 2-year ratios for the change in bone density compared with baseline.
Results
Bone density was greater in patients who had surface replacement arthroplasties than for patients who had THAs at 6 months and 1 year in Gruen Zones 1, 2, 6, and 7, with the largest increase in femoral neck bone density on the tension side at 6 months in Zone L1. We saw no decrease in bone density in patients who had surface replacement arthroplasties in any Gruen zone at any time, and observed no decrease in bone density in female patients.
Conclusions
Increased bone density at 6 months postoperatively in patients who had surface replacement arthroplasties provides evidence that clinically relevant stress shielding does not occur after surface replacement arthroplasty. Owing to the increased bone mineral density at 6 months, we believe patients who underwent surface replacement arthroplasties may to return to high-impact activities at that time without increased risk of fracture.
doi:10.1007/s11999-011-2131-4
PMCID: PMC3237978  PMID: 22006198
9.  Aspirin Decreases Heterotopic Ossification After Hip Resurfacing 
Background
Heterotopic ossification (HO) is a concern for patients undergoing hip surgery, especially surface replacement arthroplasty (SRA) who tend to be younger, more active, and anticipate good motion. It is unclear, however, whether HO occurs more frequently after SRA than traditional total hip arthroplasty (THA) and whether aspirin influences the risk.
Questions/purposes
We therefore determined the incidence of HO after hip resurfacing compared with THA and determined whether aspirin influenced the incidence or severity of HO.
Methods
Retrospectively we compared three patient cohorts: SRA with aspirin (176 hips; 160 patients), SRA with warfarin (60 hips; 57 patients), and THA with warfarin (240 hips; 222 patients). All patients satisfied the same selection criteria and all surgeries were performed through the posterolateral approach using spinal anesthesia. HO was classified using the technique of Brooker et al. comparing the preoperative, immediate postoperative, and 6- to 12-month followup radiographs (minimum, 1 year; mean, 2.7 years).
Results
In the SRA with aspirin group, HO was detected in four of 151 hips (2.6%; two Grade I; one Grade II; one Grade III); in the SRA with warfarin group, eight of 46 hips (17.4%) had HO with four hips (8.7%) having severe HO (Grade III). All 12 patients with HO in both SRA groups were male. The HO incidence and severity was less for the SRA patients treated with aspirin compared with those treated with warfarin. In the THA with warfarin control group, HO was detected in five of 189 hips (2.6%; two Grade I; three Grade II). The HO incidence and severity were the same between the THA with warfarin and the SRA with aspirin cohorts.
Conclusions
The risk of HO is greater in SRA than in THA in patients treated with warfarin postoperatively; aspirin appears to decrease the incidence and severity of HO after hip resurfacing surgery to a similar level as total hip arthroplasty.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-011-1846-6
PMCID: PMC3094639  PMID: 21409458
10.  The Incidence of Acetabular Osteolysis in Young Patients With Conventional versus Highly Crosslinked Polyethylene 
Background
Osteolysis is a major mode of hip implant failure. Previous literature has focused on the amount of polyethylene wear comparing highly crosslinked polyethylene (HXPLE) with conventional liners but has not clarified the relative incidence of osteolysis with these two liners.
Questions/purposes
We determined (1) the incidence of osteolysis in HXLPE versus conventional polyethylene (CPE), (2) the ability to detect and evaluate the size of lytic lesions using radiographs compared with CT scans, (3) head penetration in hips without and with lysis, and (4) determined whether acetabular position, head size, and UCLA activity score contributed to lysis.
Methods
We compared head penetration and osteolysis on plain radiographs and presence and volume of osteolysis on CT scans in 48 patients with HXLPE (mean, 46.5 years) and 50 patients with CPE (mean, 43.2 years). The minimum followup was 5 years (average, 7.2 years; range, 5.1–10.9 years),
Results
Osteolysis was apparent on CT in a larger number of patients with CPE liners than HXLPE liners: 12 of 50 (24%) versus one of 48 (2%), respectively. We found no correlation between head penetration and volume of osteolytic lesions. Head penetration was greater in patients with osteolysis. Smaller head sizes were associated with greater wear and those with osteolysis had smaller head sizes; however, there was no difference in acetabular component position or UCLA activity in those with lysis compared with those without.
Conclusions
HXLPE diminished the incidence of osteolysis, but the lack of correlation between penetration and volume of osteolysis suggests other factors other than wear contribute to the development of osteolysis.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-010-1518-y
PMCID: PMC3018187  PMID: 20824407
11.  The Frank Stinchfield Award: The Impact of Socioeconomic Factors on Outcome After THA: A Prospective, Randomized Study 
Background
Most studies of total hip arthroplasty (THA) focus on the effect of the type of implant on the clinical result. Relatively little data are available on the impact of the patient’s preoperative status and socioeconomic factors on the clinical results following THA.
Questions/purposes
We determined the relative importance of patient preoperative and socioeconomic status compared to implant and technique factors in predicting patient outcome as reflected by scores on commonly utilized rating scales (eg, Harris Hip Score, WOMAC, SF-12, degree of patient satisfaction, or presence or severity of thigh pain) following cementless THA.
Methods
All patients during the study period were offered enrollment in a prospective, randomized study to receive either a titanium, tapered, proximally coated stem; or a Co-Cr, cylindrical, extensively coated stem; 102 patients were enrolled. We collected detailed patient data preoperatively including diagnosis, age, gender, insurance status, medical comorbidities, tobacco and alcohol use, household income, educational level, and history of treatment for lumbar spine pathology. Clinical evaluation included Harris Hip Score, SF-12, WOMAC, pain drawing, and UCLA activity rating and satisfaction questionnaire. Implant factors included stem type, stem size, fit in the canal, and stem-bone stiffness ratios. Minimum 2 year followup was obtained in 95% of the enrolled patients (102 patients).
Results
Patient demographics and preoperative status were more important than implant factors in predicting the presence of thigh pain, dissatisfaction, and a low hip score. The most predictive factors were ethnicity, educational level, poverty level, income, and a low preoperative WOMAC score or preoperative SF-12 mental component score. No implant parameter correlated with outcome or satisfaction.
Conclusion
Socioeconomic factors and preoperative status have more impact on the clinical outcome of cementless THA than implant related factors.
Level of Evidence
Level I, prospective, randomized clinical trial. See the guidelines online for a complete description of level of evidence.
doi:10.1007/s11999-010-1519-x
PMCID: PMC3018201  PMID: 20717856
12.  The Fate of Grafting Acetabular Defects During Revision Total Hip Arthroplasty 
Background
Acetabular defects are frequently grafted during revision THA. Previous studies using plain radiographs report high rates of graft incorporation. However, given plain radiographs underestimate osteolysis, it is unclear whether plain radiographs adequately reflect graft fill or incorporation.
Questions/purposes
We determined if (1) graft fill; or (2) incorporation (measured as graft–bone contact) differed with complete revision and grafting compared to liner exchange and grafting; (3) defect fill and incorporation could be assessed on plain radiographs; and (4) the cost of bone grafting differed with these two procedures.
Methods
We identified 40 patients who underwent revision THA for aseptic loosening or polyethylene wear and osteolysis, either with retention of a well-fixed cup or complete acetabular revision in which bone graft was used. Lesion size, percent fill, and graft healing was quantified from CT scans. A limited cost analysis was performed using the current hospital costs for implants, bone grafts, and bone graft substitutes. The minimum followup was 1 year (mean, 4.8 years; range, 1–11 years).
Results
The average defect fill was 30% (range, 0%–81%). The average percent of healing to host bone was 24% (range, 0–66%). Complete revisions had a higher percent defect fill compared to head/liner changes (47% versus 17%) as well as a higher degree of graft healing to host bone compared to head/liner changes (36% versus 14%). High resolution CT demonstrated lower percentages of defect fill and graft healing than previous reports based on plain radiographs. Bone grafting costs exceeded implant costs in the head/liner exchange group; however, the overall cost was higher in the complete revision group.
Conclusions
Higher degrees of defect fill and healing were seen with complete revisions compared to head/liner exchanges. Compared to CT scans, plain radiograph assessment tended to overestimate defect fill and healing.
Level of Evidence
Level III, therapeutic study. See the guidelines online for a complete description of level of evidence.
doi:10.1007/s11999-010-1427-0
PMCID: PMC2974866  PMID: 20577842
13.  Proximally Versus Fully Porous-coated Femoral Stems: A Multicenter Randomized Trial 
There are two broad-based categories of cementless femoral component designs: proximally porous-coated and fully porous-coated. While both have been widely used, there remains debate regarding differences in clinical outcome scores, relative incidence of thigh pain, and development of stress shielding. We investigated these variables in a multicenter prospective randomized blinded clinical trial of 388 patients from three centers: 198 patients had a proximally porous-coated tapered cementless femoral component and 190 patients had a fully porous-coated cementless femoral component. A minimum followup of 2 years (mean, 6.7 years; range, 2.0–8.65 years) was available in 367 of the 388 patients (95%). We observed no differences in age at surgery, body mass index, or preoperative clinical outcome scores (WOMAC, SF-12, Harris hip score, UCLA activity, thigh pain) with the two groups. We determined serial bone density changes in a subcohort of 72 patients from two of the three centers. The postoperative clinical outcome scores were similar at all followup intervals, and we observed no differences in the incidence of thigh pain at any time. Bone density reduction in Gruen Zone 7 was greater with the fully coated stem than the proximally coated stem (24% versus 15% reduction, respectively). Both fully and proximally coated stems performed well, with no clinical differences at 2 years’ followup, except in bone mineral density evaluations.
Level of Evidence: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-009-1092-3
PMCID: PMC2806990  PMID: 19777316
14.  The Learning Curve for Adopting Hip Resurfacing Among Hip Specialists 
Patient demand and surgeon interest in hip resurfacing has recently increased, but surgeons in the United States are relatively inexperienced with this procedure. We determined the learning curve associated with hip resurfacing and compared the rate of early complications of the first 650 hip resurfacings between five experienced hip surgeons and a national safety survey database study we previously published, which included 89 surgeons and 537 hip resurfacings. Patient demographics and adverse events were recorded. Specific features on pre- and postoperative radiographs were measured in a blinded fashion by a single observer. There were 13 major complications (2.0%), which is 3.7 times lower than our national safety survey complication rate of 7.4%. All fractures occurred in the first 25 cases performed. The complication rate was higher for the first 25 procedures (5.6%) compared with the second 25 procedures (1.6%). For experienced hip surgeons, the learning curve for avoiding early complications was short, 25 cases or less. The learning curve for achieving the desired component positioning radiographically was much longer, 75 to 100 cases or more. If achieving some ideal component position proves important for long-term function and implant survival, improved instrumentation and surgical techniques would be necessary to shorten the learning curve.
Level of Evidence: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-009-1106-1
PMCID: PMC2807001  PMID: 19779950
15.  Iliopsoas Bursa Injections Can be Beneficial for Pain after Total Hip Arthroplasty 
Impingement of the iliopsoas tendon is an uncommon cause of groin pain after total hip arthroplasty (THA). We asked whether selective steroid and anesthetic injections for iliopsoas tendonitis after THA would relieve pain and improve function. We retrospectively reviewed 27 patients with presumed iliopsoas tendinitis treated by fluoroscopically guided injections of the iliopsoas bursa. Pre- and immediately postinjection, questionnaires and telephone followup questionnaires were administered to determine patient outcomes. Four patients were lost to followup and we were unable to obtain information from relatives on an additional four; the questionnaire was administered to the remaining 19 patients, including six who subsequently had surgery at an average of 44.6 months (range, 25–68 months) after their first injection. The average modified Harris hip score in the 19 patients improved from 61 preinjection to 82 postinjection and the average pain improved from 6.4 preinjection to 2.9 postinjection, but eight patients (30%) required a second injection at an average of 8.2 months after the first injection. Ultimately, six patients (22%) had an additional surgical procedure to address the underlying cause of the iliopsoas irritation. Iliopsoas tendonitis is uncommon after THA but should be considered in the differential diagnosis of all patients who present with groin pain after THA. Selective steroid and anesthetic injections of the iliopsoas bursa give adequate pain relief in the majority of patients and should be considered part of the nonoperative treatment plan before surgical release of the iliopsoas tendon or component revision.
Level of Evidence: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
Electronic supplementary material
The online version of this article (doi:10.1007/s11999-009-1141-y) contains supplementary material, which is available to authorized users.
doi:10.1007/s11999-009-1141-y
PMCID: PMC2807015  PMID: 19851816
16.  Prophylactic Antibiotics Do Not Affect Cultures in the Treatment of an Infected TKA: A Prospective Trial 
Prophylactic antibiotics are frequently withheld until cultures are obtained in revision total knee arthroplasty (TKA). We undertook a prospective study to determine whether prophylactic preoperative intravenous antibiotics would affect the results of cultures obtained intraoperatively. We enrolled 25 patients with 26 infected TKAs, a known preoperative infecting organism, and no recent antibiotic therapy. Reaspiration of the infected TKA was performed after anesthesia and sterile preparation. Intravenous antibiotic prophylaxis was then administered and the tourniquet inflated. Intraoperative culture swabs and tissue were obtained at arthrotomy. The timing of events was recorded. Pre- and postantibiotic culture data were analyzed to determine the effect of intravenous preoperative prophylactic antibiotics on cultures obtained intraoperatively. Infections were acute postoperative (four), chronic (19), and acute hematogenous (three). The most common infecting organism was cloxacillin-sensitive Staphylococcus aureus (nine knees [35%]). Preoperative prophylactic antibiotics did not affect the results of intraoperative cultures and we therefore believe should not be withheld before surgery for an infected TKA when an organism has been identified on aspiration preoperatively, and there has been no recent (4 weeks) antimicrobial therapy.
Level of Evidence: Level II, diagnostic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-009-1014-4
PMCID: PMC2795808  PMID: 19669849
17.  Correlation of Computed Tomography with Histology in the Assessment of Periprosthetic Defect Healing 
Computed tomography (CT) may more accurately assess the healing of grafted osteolytic lesions around acetabular components compared with plain radiographs, although clinical validation is lacking. To determine whether clinical or micro-CT imaging could assess accurately the grafted lesion compared with histology, we therefore quantified bone healing and ingrowth to determine an effective rhBMP-2 dose and ratio to allograft bone when grafted adjacent to a cementless porous-coated component. We grafted surgically created acetabular defects in canines (n = 20) before uncemented total hip arthroplasty. At 6 weeks, embedded acetabula were imaged and the CT slice images matched to histology section images. The percentage of bone in the defect and growth into the porous surface was assessed quantitatively. Low-dose rhBMP-2 with allograft (1:5 ratio) resulted in a higher percentage of defect healing (43.8%) than rhBMP-2 alone (29.2%) and a higher percentage of bone ingrowth (15.7%) than allograft bone alone (1.1%) as measured by histology. Micro-CT measurements were similar to histologic measurements of defect healing, whereas clinical CT overestimated periprosthetic bone by 38%. Neither clinical CT nor micro-CT techniques are adequate for assessing ingrowth or the bone-implant interface with metal artifacts.
doi:10.1007/s11999-009-1087-0
PMCID: PMC2772920  PMID: 19756903
19.  Is Patient Selection Important for Hip Resurfacing? 
The optimal implant option for hip arthroplasty in the young, active patient remains controversial. There has been renewed interest for metal-on-metal hip resurfacing due to improved design and manufacturing of implants, better materials, enhanced implant fixation, theoretical advantages over conventional total hip arthroplasty, and recent Food and Drug Administration approval of two devices. Recent studies indicate satisfactory short- and midterm clinical results (1- to 10-year followup) with low complication rates, but there is a learning curve associated with this procedure, a more extensive surgical approach is necessary, and long-term results have yet to be determined. Proper patient selection may help avoid complications and improve patient outcomes. Patient selection criteria in the literature appear based predominantly on theoretical considerations without any consensus on stratifying patient risk. The most commonly reported complications encountered with hip resurfacing include femoral neck fracture, acetabular component loosening, metal hypersensitivity, dislocation, and nerve injury. At the time of clinical evaluation, patient age; gender; diagnosis; bone density, quality, and morphology; activity level; leg lengths; renal function; and metal hypersensitivity are important factors when considering a patient for hip resurfacing. Based on our review, we believe the best candidates for hip resurfacing are men under age 65 with osteoarthritis and relatively normal bony morphology.
Level of Evidence: Level V, prognostic study. See the Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-008-0558-z
PMCID: PMC2601008  PMID: 18941859
20.  Initial American Experience with Hip Resurfacing Following FDA Approval 
In May 2006, the US Food and Drug Administration approved the first metal-on-metal total hip resurfacing. Surgeons wanting to implant this device were required to undergo formal industry-sponsored training before performing their first case and a technical specialist attended their initial 10 cases. Safety surveys were completed on the first 537 cases performed and included patient age, gender, diagnosis, and occurrence of any unexpected events perioperatively or postoperatively. Intraoperative data were available for all 537 cases (100%), hospital discharge and six-week data were available for 524 cases (97.6%), three-month data were available for 523 cases (97.4%), six-month data were available for 509 cases (94.3%) and one-year data were available for 449 cases (83.6%); the mean followup was 10.4 months. We documented adverse events in 40 (32 major, 8 minor) of the 537 cases including nine nerve injuries and eight dislocations. There were 14 component revisions (7.4%) within the first year, including 10 for femoral neck fracture, two for dislocations, and two for acetabular component loosening. Complications were frequently seen among patients older than 55 years of age and in women, emphasizing the importance of appropriate patient selection for the procedure.
Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-008-0563-2
PMCID: PMC2600981  PMID: 18949528
21.  Diagnosis of Infected Total Knee: Findings of a Multicenter Database 
Although total knee arthroplasty (TKA) is an effective and successful procedure, the outcome is occasionally compromised by complications including periprosthetic joint infection (PJI). Accurate and early diagnosis is the first step in effectively managing patients with PJI. At the present time, diagnosis remains dependent on clinical judgment and reliance on standard clinical tests including serologic tests, analysis of aspirated joint fluid, and interpretation of intraoperative tissue and fluid test results. Although reports regarding sensitivity and specificity of all diagnostic tests in the literature are abundant, the interpretation of the available data has been hampered by the low sample size of these studies. In view of the scope of this important problem and the limitations of previous reports, a large database was assembled of all revision TKA performed at three academic referral centers in order to determine the current status of diagnosis of the infected TKA utilizing commonly available tests. Intraoperative cultures should not be used as a gold standard for PJI owing to high percentages of false-negative and false-positive cases. When combined with clinical judgment, total white cell count and percentage of neutrophils in the synovial fluid more accurately reflects PJI and when combined with hematologic exams safely excludes or confirms infection.
Level of Evidence: Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-008-0471-5
PMCID: PMC2565043  PMID: 18781372
22.  Pharmacogenetic Warfarin Dose Refinements Remain Significantly Influenced by Genetic Factors after One Week of Therapy 
Thrombosis and Haemostasis  2011;107(2):232-240.
Summary
Introduction
By guiding initial warfarin dose, pharmacogenetic (PGx) algorithms may improve the safety of warfarin initiation. However, once INR response is known, the contribution of PGx to dose refinements is uncertain. This study sought to develop and validate clinical and PGx dosing algorithms for warfarin dose refinement on days 6–11 after therapy initiation.
Materials and Methods
An international sample of 2,022 patients at 13 medical centers on 3 continents provided clinical, INR, and genetic data at treatment days 6–11 to predict therapeutic warfarin dose. Independent derivation and retrospective validation samples were composed by randomly dividing the population (80%/20%). Prior warfarin doses were weighted by their expected effect on S-warfarin concentrations using an exponential-decay pharmacokinetic model. The INR divided by that “effective” dose constituted a treatment response index.
Results
Treatment response index, age, amiodarone, body surface area, warfarin indication, and target INR were associated with dose in the derivation sample. A clinical algorithm based on these factors was remarkably accurate: in the retrospective validation cohort its R2 was 61.2% and median absolute error (MAE) was 5.0 mg/week. Accuracy and safety was confirmed in a prospective cohort (N=43). CYP2C9 variants and VKORC1-1639 G→A were significant dose predictors in both the derivation and validation samples. In the retrospective validation cohort, the PGx algorithm had: R2= 69.1% (P<0.05 vs. clinical algorithm), MAE= 4.7 mg/week.
Conclusions
A pharmacogenetic warfarin dose-refinement algorithm based on clinical, INR, and genetic factors can explain at least 69.1% of therapeutic warfarin dose variability after about one week of therapy.
doi:10.1160/TH11-06-0388
PMCID: PMC3292349  PMID: 22186998
warfarin; VKORC1; CYP2C9; pharmacogenetic
23.  Laboratory and Clinical Outcomes of Pharmacogenetic vs. Clinical Protocols for Warfarin Initiation in Orthopedic Patients 
Background
Warfarin is commonly prescribed for prophylaxis and treatment of thromboembolism after orthopedic surgery. During warfarin initiation, out-of-range International Normalized Ratio (INR) values and adverse events are common.
Methods
In orthopedic patients beginning warfarin therapy, we developed and prospectively validated pharmacogenetic and clinical dose refinement algorithms to revise the estimated therapeutic dose after 4 days of therapy.
Results
The pharmacogenetic algorithm used the cytochrome P450 (CYP) 2C9 genotype, smoking status, perioperative blood loss, liver disease, INR values, and dose history to predict the therapeutic dose. The R2 was 82% in a derivation cohort (N = 86), and 70% when used prospectively (N = 146). The R2 of the clinical algorithm that used INR values and dose history to predict the therapeutic dose was 57% in a derivation cohort (N = 178), and 48% in a prospective validation cohort (N = 146). In one month of prospective follow-up, the percent time spent in the therapeutic range was 7% higher (95% CI: 2.7%–11.7%) in the pharmacogenetic cohort. The risk of laboratory or clinical adverse event was also significantly reduced in the pharmacogenetic cohort (Hazard Ratio 0.54; 95% CI: 0.29–0.97).
Conclusions
Warfarin dose adjustments that incorporate genotype and clinical variables available after four warfarin doses are accurate. In this non-randomized, prospective study, pharmacogenetic dose refinements were associated with more time spent in the therapeutic range and fewer laboratory or clinical adverse events. To facilitate gene-guided warfarin dosing we created a non-profit website, www.WarfarinDosing.org.
doi:10.1111/j.1538-7836.2008.03095.x
PMCID: PMC2920450  PMID: 18662264
Warfarin; Pharmacogenetics; Dosing Algorithm; Anticoagulants; Orthopedic Surgery

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