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1.  Autologous bone graft versus demineralized bone matrix in internal fixation of ununited long bones 
Background
Non-unions are severe complications in orthopaedic trauma care and occur in 10% of all fractures. The golden standard for the treatment of ununited fractures includes open reduction and internal fixation (ORIF) as well as augmentation with autologous-bone-grafting. However, there is morbidity associated with the bone-graft donor site and some patients offer limited quantity or quality of autologous-bone graft material. Since allogene bone-grafts are introduced on the market, this comparative study aims to evaluate healing characteristics of ununited bones treated with ORIF combined with either iliac-crest-autologous-bone-grafting (ICABG) or demineralized-bone-matrix (DBM).
Methods and results
From 2000 to 2006 out of sixty-two consecutive patients with non-unions presenting at our Level I Trauma Center, twenty patients had ununited diaphyseal fractures of long bones and were treated by ORIF combined either by ICABG- (n = 10) or DBM-augmentation (n = 10). At the time of index-operation, patients of the DBM-group had a higher level of comorbidity (ASA-value: p = 0.014). Mean duration of follow-up was 56.6 months (ICABG-group) and 41.2 months (DBM-group). All patients were clinically and radiographically assessed and adverse effects related to bone grafting were documented. The results showed that two non-unions augmented with ICABG failed osseous healing (20%) whereas all non-unions grafted by DBM showed successful consolidation during the first year after the index operation (p = 0.146). No early complications were documented in both groups but two patients of the ICABG-group suffered long-term problems at the donor site (20%) (p = 0.146). Pain intensity were comparable in both groups (p = 0.326). However, patients treated with DBM were more satisfied with the surgical procedure (p = 0.031).
Conclusion
With the use of DBM, the costs for augmentation of the non-union-site are more expensive compared to ICABG (calculated difference: 160 €/case). Nevertheless, this study demonstrated that the application of DBM compared to ICABG led to an advanced outcome in the treatment of non-unions and simultaneously to a decreased quantity of adverse effects. Therefore we conclude that DBM should be offered as an alternative to ICABG, in particular to patients with elevated comorbidity and those with limited availability or reduced quality of autologous-bone graft material.
doi:10.1186/1752-2897-3-11
PMCID: PMC2801473  PMID: 20003511
2.  Injection of Demineralized Bone Matrix With Bone Marrow Concentrate Improves Healing in Unicameral Bone Cyst 
Background
Unicameral bone cysts are benign lesions that usually spontaneously regress with skeletal maturity; however, the high risk of pathologic fractures often justifies treatment that could reinforce a weakened bone cortex. Various treatments have been proposed but there is no consensus regarding the best procedure.
Questions/purposes
We compared the healing rates and failures of two methods of cure based on multiple injections of corticosteroid or a single injection of demineralized bone matrix (DBM) in association with bone marrow concentrate (BMC).
Methods
We retrospectively reviewed 184 patients who had one of the two treatments for unicameral bone cysts with cortical erosion. Clinical records were reviewed for treatment failures and radiographs for healing in all patients. The minimum followup was 12 months for the Steroids Group (mean, 48 months; range, 12–120 months) and 12 months for the DBM + BMC Group (mean, 20 months; range, 12–28 months).
Results
After one treatment we observed a lower healing rate of cysts treated with multiple injections of steroids compared with the healing after the first injection of DBM + BMC (21% versus 58%, respectively). At last followup, 38% healed with steroids and 71% with DBM + BMC. The rate of failure after one steroid injection was higher than after a single injection of BDM + BMC (63% versus 24%, respectively). We observed no difference in fracture rates after treatment between the two groups.
Conclusions
A single injection of DBM added with autologous bone marrow concentrate appears to provide a higher healing rate with a lower number of failures compared with a single injection of steroids.
Level of Evidence
Level III, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-010-1430-5
PMCID: PMC2947677  PMID: 20568027
3.  Minimal invasive surgery for unicameral bone cyst using demineralized bone matrix: a case series 
Background
Various treatments for unicameral bone cyst have been proposed. Recent concern focuses on the effectiveness of closed methods. This study evaluated the effectiveness of demineralized bone matrix as a graft material after intramedullary decompression for the treatment of unicameral bone cysts.
Methods
Between October 2008 and June 2010, twenty-five patients with a unicameral bone cyst were treated with intramedullary decompression followed by grafting of demineralized bone matrix. There were 21 males and 4 female patients with mean age of 11.1 years (range, 3–19 years). The proximal metaphysis of the humerus was affected in 12 patients, the proximal femur in five, the calcaneum in three, the distal femur in two, the tibia in two, and the radius in one. There were 17 active cysts and 8 latent cysts. Radiologic change was evaluated according to a modified Neer classification. Time to healing was defined as the period required achieving cortical thickening on the anteroposterior and lateral plain radiographs, as well as consolidation of the cyst. The patients were followed up for mean period of 23.9 months (range, 15–36 months).
Results
Nineteen of 25 cysts had completely consolidated after a single procedure. The mean time to healing was 6.6 months (range, 3–12 months). Four had incomplete healing radiographically but had no clinical symptom with enough cortical thickness to prevent fracture. None of these four cysts needed a second intervention until the last follow-up. Two of 25 patients required a second intervention because of cyst recurrence. All of the two had a radiographical healing of cyst after mean of 10 additional months of follow-up.
Conclusions
A minimal invasive technique including the injection of DBM could serve as an excellent treatment method for unicameral bone cysts.
doi:10.1186/1471-2474-13-134
PMCID: PMC3475132  PMID: 22839754
4.  Grafting Using Injectable Calcium Sulfate in Bone Tumor Surgery: Comparison with Demineralized Bone Matrix-based Grafting 
Clinics in Orthopedic Surgery  2011;3(3):191-201.
Background
Injectable calcium sulfate is a clinically proven osteoconductive biomaterial, and it is an injectable, resorbable and semi-structural bone graft material. The purpose of this study was to validate the clinical outcomes of injectable calcium sulfate (ICS) grafts as compared with those of a demineralized bone matrix (DBM)-based graft for filling in contained bony defects created by tumor surgery.
Methods
Fifty-six patients (41 males and 15 females) with various bone tumors and who were surgically treated between September 2003 and October 2007 were included for this study. The patients were randomly allocated into two groups, and either an ICS graft (28 patients) or a DBM-based graft (28 patients) was implanted into each contained defect that was developed by the surgery. The radiographic outcomes were compared between the two groups and various clinical factors were included for the statistical analysis.
Results
When one case with early postoperative pathologic fracture in the DBM group was excluded, the overall success rates of the ICS and DBM grafting were 85.7% (24/28) and 88.9% (24/27) (p > 0.05), respectively. The average time to complete healing was 17.3 weeks in the ICS group and 14.9 weeks in the DBM group (p > 0.05). Additionally, the ICS was completely resorbed within 3 months, except for one case.
Conclusions
Although the rate of resorption of ICS is a concern, the injectable calcium sulfate appears to be a comparable bone graft substitute for a DBM-based graft, with a lower cost, for the treatment of the bone defects created during surgery for various bone tumors.
doi:10.4055/cios.2011.3.3.191
PMCID: PMC3162199  PMID: 21909466
Injectable calcium sulfate; Demineralized bone matrix; Bone tumor
5.  Osteogenic Protein-1 for Long Bone Nonunion 
Executive Summary
Objective
To assess the efficacy of osteogenic protein-1 (OP-1) for long bone nonunion.
Clinical Need
Although most fractures heal within a normal period, about 5% to 10% do not heal and are classified as delayed or nonunion fractures. Nonunion and segmental bone loss after fracture, reconstructive surgery, or lesion excision can present complex orthopedic problems, and the multiple surgical procedures often needed are associated with patient morbidity and reduced quality of life.
Many factors contribute to the pathogenesis of a delayed union or nonunion fractures, including deficiencies of calcium, vitamin D, or vitamin C, and side effects of medications such as anticoagulants, steroids, some anti-inflammatory drugs, and radiation. It has been shown that smoking interferes with bone repair in several ways.
Incidence of Nonunion and Delayed Union Cases
An estimated 5% to 10% of fractures do not heal properly and go on to delayed union or nonunion. If this overall estimate of incidence were applied to the Ontario population1, the estimated number of delayed union or nonunion in the province would be between 3,863 and 7,725.
Treatment of Nonunion Cases
The treatment of nonunion cases is a challenge to orthopedic surgeons. However, the basic principle behind treatment is to provide both mechanical and biological support to the nonunion site.
Fracture stabilization and immobilization is frequently used with the other treatment modalities that provide biological support to the fractured bone. Biological support includes materials that could be served as a source of osteogenic cells (osteogenesis), a stimulator of mesenchymal cells (osteoinduction), or a scaffold-like structure (osteoconduction).
The capacity to heal a fracture is a latent potential of the stromal stem cells, which synthesize new bone. This process has been defined as osteogenesis. Activation of the stem cells to initiate osteogenic response and to differentiate into bone-forming osteoblasts is called osteoinduction. These 2 properties accelerate the rate of fracture healing or reactivate the ineffective healing process. Osteoconduction occurs when passive structures facilitate the migration of osteoprogenitor cells, the perivascular tissue, and capillaries into these structures.
Bone Grafts and Bone Graft Substitutes
Bone graft and bone graft substitutes have one or more of the following components:
Undifferentiated stem cells
Growth factors
Structural lattice
Undifferentiated stem cells are unspecialized, multipotential cells that can differentiate into a variety of specialized cells. They can also replicate themselves. The role of stem cells is to maintain and repair the tissue in which they are residing. A single stem cell can generate all cell types of that tissue. Bone marrow is a source of at least 2 kinds of stem cells. Hematopoietic stem cells that form all types of blood cells, and bone marrow stromal stem cells that have osteogenic properties and can generate bone, cartilage, and fibrous tissue.
Bone marrow has been used to stimulate bone formation in bone defects and cases of nonunion fractures. Bone marrow can be aspirated from the iliac crest and injected percutaneously with fluoroscopic guidance into the site of the nonunion fracture. The effectiveness of this technique depends on the number and activity of stem cells in the aspirated bone marrow. It may be possible to increase the proliferation and speed differentiation of stem cells by exposing them to growth factor or by combining them with collagen.
Many growth factors and cytokines induced in response to injury are believed to have a considerable role in the process of repair. Of the many bone growth factors studied, bone morphogenetics (BMPs) have generated the greatest attention because of their osteoinductive potential. The BMPs that have been most widely studied for their ability to induce bone regeneration in humans include BMP-2 and BMP-7 (osteogenic protein). Human osteogenic protein-1 (OP-1) has been cloned and produced with recombinant technology and is free from the risk of infection or allergic reaction.
The structural lattice is osteoconductive; it supports the ingrowth of developing capillaries and perivascular tissues. Three distinct groups of structural lattice have been identified: collagen, calcium sulphate, and calcium phosphate. These materials can be used to replace a lost segment of bone.
Grafts Used for Nonunion
Autologous bone graft is generally considered the gold standard and the best material for grafting because it contains several elements that are critical in promoting bone formation, including osteoprogenitor cells, the matrix, and bone morphogenetic proteins. The osteoconductive property of cancellous autograft is related to the porosity of bone. The highly porous, scaffold-like structure of the graft allows host osteoblasts and host osteoprogenitor cells to migrate easily into the area of the defect and to begin regeneration of bone. Sources of cancellous bone are the iliac crest, the distal femur, the greater trochanter, and the proximal tibia. However, harvesting the autologous bone graft is associated with postoperative pain at the donor site, potential injury to the surrounding arteries, nerves, and tissues, and the risk of infection. Thus the development of synthetic materials with osteoconductive and osteoinductive properties that can eliminate the need for harvesting has become a major goal of orthopedic research.
Allograft is the graft of tissue between individuals who are of the same species but are of a disparate genotype. Allograft has osteoconductive and limited osteoinductive properties. Demineralized bone matrix (DBM) is human cortical and cancellous allograft. These products are prepared by acid extraction of allograft bone, resulting in the loss of most of the mineralized component while collagen and noncollagenous proteins, including growth factors, are retained. Figures 1 to 5 demonstrate the osteogenic, osteoinduction, and osteoconduction properties of autologous bone graft, allograft, OP-1, bone graft substitutes, and bone marrow.
Autologous Bone Graft
Osteogenic Protein-1
Allograft bone and Demineralized Bone Matrix
Bone Graft Substitutes
Autologous Bone Marrow Graft
New Technology Being Reviewed: Osteogenic Protein-1
Health Canada issued a Class IV licence for OP-1 in June 2004 (licence number 36320). The manufacturer of OP-1 is Stryker Biotech (Hapkinton, MA).
The United States Food and Drug Administration (FDA) issued a humanitarian device exemption for the application of the OP-1 implant as an “alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.” Regulatory agencies in Europe, Australia, and New Zealand have permitted the use of this implant in specific cases, such as in tibial nonunions, or in more general cases, such as in long bone nonunions.
According to the manufacturer, OP-1 is indicated for the treatment of long bone nonunions. It is contraindicated in the patient has a hypersensitivity to the active substance or collagen, and it should not be applied at the site of a resected tumour that is at or near the defect or fracture. Finally, it should not be used in patients who are skeletally immature (< 18 years of age), or if there is no radiological evidence of closure of epiphysis.
Review Strategy
Objective
To summarize the safety profile and effectiveness of OP-1 in the treatment of cases of long bone nonunion and bone defects
To compare the effectiveness and cost effectiveness of OP-1 in the treatment of long bone nonunions and bone defects with the alternative technologies, particularly the gold standard autologous bone graft.
Literature Search
International Network of Agencies for Health Technology Assessments (INAHTA), the Cochrane Database of Systematic Reviews and the CCTR (formerly Cochrane Controlled Trials Register) were searched for health technology assessments. MEDLINE, EMBASE, Medline In Process and Other Non-Indexed Citations were searched from January 1, 1996 to January 27, 2004 for studies on OP-1. The search was limited to English-language articles and human studies. The search yielded 47 citations. Three studies met inclusion criteria (2 RCTs and 1 Ontario-based study presented at an international conference.
Summary of Findings
Friedlaender et al. conducted a prospective, randomized, partially blinded clinical trial on the treatment tibial nonunions with OP-1. Tibial nonunions were chosen for this study because of their high frequency, challenging treatment requirements, and substantial morbidity. All of the nonunions were at least 9 months old and had shown no progress toward healing over the previous 3 months. The patients were randomized to receive either treatment with autologous bone grafting or treatment with OP-1 in a type-1 collagen carrier. Both groups received reduction and fixation with an intramedullary rod. Table 1 summarizes the clinical outcomes of this study.
Outcomes in a Randomized Clinical Trial on Tibial Nonunions: Osteogenic Protein-1 versus Autologous Bone Grafting
Clinical success was defined as full weight-bearing, loss of severe pain at the fracture site on weight-bearing, and no further surgical treatment to enhance fracture repair.
The results of this study demonstrated that recombinant OP-1 is associated with substantial clinical and radiographic success for the treatment of tibial nonunions when used with intramedullary rod fixation. No adverse event related to sensitization was reported. Five per cent of the patients in the OP-1 group had circulating antibodies against type 1 collagen. Only 10% of the patients had a low level of anti-OP-1 antibodies, and all effects were transient. Furthermore, the success rate with the OP-1 implant was comparable with those achieved with autograft at 9 and 24 months follow-up. Eighty-two per cent of patients were successful at 24 months follow-up in both groups.
Statistically significant increased blood loss in the group treated with the autograft was observed (P = .049). Patients treated with autograft had longer operation and hospitalization times. All patients in the autograft group had pain at the donor site after surgery, and more than 80% judged their postoperative pain as moderate or severe. At their 6-month visit, 20% of the patients in the autograft group had persistent pain, mild or moderate in nature, at the donor site. This number fell to 13% at 12 months.
All patients in each of the groups had at least 1 adverse event that wasn’t serious, such as fever, nausea and vomiting, leg edema, discomfort, and bruising at the operative site. The incidence of these events was similar in both groups. Serious adverse events were observed in 44% of both groups, none of which were considered related to the OP-1 implant or autograft.
On the basis of this data, the FDA issued a humanitarian device exemption for the application of OP-1 implant as an alternative to autograft in recalcitrant long bone nonunions when the use of autograft is unfeasible and alternative treatments have failed.
Study on Fibular Defects
Geesink et al. investigated the osteogenic activity of OP-1 by assessing its value in bridging fibular defects made at the time of tibial osteotomy for varus or valgus deformity of the knee. This study had 2 phases and included 12 patients in each phase. Each phase included 12 patients (6 in each group). Patients in the first phase received either DBM or were left untreated. Patients in the second phase received either OP-1 on collagen type-1 or collagen type-1 alone.
Radiological and Dual Energy X-ray Absorptiometry (DEXA) evaluation showed that in patients in whom the defect was left untreated, no formation of bone occurred. At 12 months follow-up, new bone formation with bridging occurred in 4 of the 6 patients in DMB group, and 5 of the 6 patients in OP-1 group. One patient in OP-1 group did not show any evidence of new bone formation at any point during the study.
Ontario Pilot Study
A prospective pilot study was conducted in Ontario, Canada to investigate the safety and efficacy of OP-1 for the treatment of recalcitrant long bone nonunions. The study looked at 15 patients with complex, recalcitrant, long bone nonunions whose previous treatment had failed. The investigators concluded that this bone graft substitute appears to be safe and effective in providing sufficient biological stimulation in difficult to treat nonunions. Results of a more complete study on 70 patients are ready for publication. According to the principal investigator, OP-1 was 90% effective in inducing bone formation and bone healing in this sample.
Alternative Technologies
The Medical Advisory Secretariat conducted a literature search from January 1, 2000 to February 28, 2005 to identify studies on nonunions/bone defects that had been treated with alternative technologies. A review of these studies showed that, in addition to the gold standard autologous bone marrow grafting, bone allografts, demineralized bone matrices, bone graft substitutes, and autologous bone marrow have been used for treatment of nonunions and bone defects. These studies were categorized according to the osteoinductive, osteoconductive, and osteogenesis properties of the technologies studied.
A review of these studies showed that bone allografts have been used mostly in various reconstruction procedures to restore the defect after excavating a bone lesion. Two studies investigated the effectiveness of DBM in healing fracture nonunions. Calcium phosphate and calcium sulphate have been used mostly for repair of bone defects.
Several investigators have looked at the use of autologous bone marrow for treatment of long bone nonunions. The results of these studies show that method of percutaneous bone marrow grafting is highly effective in the treatment of long bone nonunions. In a total of 301 fractures across all studies, 268 (89%) healed with a mean healing time of 2.5 to 8 months. This healing time as derived from these case series is less than the timing of the primary end point in Friedlaender’s study (9 months). Table 2 summarizes the results of these studies. Table 2 summarizes the results of these studies.
Studies that used Percutaneous Bone Marrow Grafting for Treatment of Nonunions
Economic Analysis
Based on annual estimated incidence of long-bone nonunion of 3,863 - 7,725, the annual hospitalization costs associated with this condition is between $21.2 and $42.3 million based on a unit cost of $5,477 per hospital separation. When utilized, the device, a single vial of OP-1, is approximately $5,000 and if adopted universally in Ontario, the total device costs would be in the range of $19.3 - $38.6 million annually. The physician fee for harvest, insertion of bone, or OP-1 is $193 and is $193 for autologous bone marrow transplantation. Total annual physician costs are expected to be in the range of from $0.7 million to $1.3 million per year. Expenditures associated with long-bone nonunion are unlikely to increase since incidence of long-bone nonunion is unlikely to change in the future. However, the rate of uptake of OP-1 could have a significant impact on costs if the uptake were large.
The use of OP-1 and autologous bone marrow transplantation may offset pain medication costs compared with those associated with autologous bone harvest given that the former procedures do not involve the pain associated with the bone harvest site. However, given that this pain is normally not permanent, the overall offset is likely to be small. There are likely to be smaller OHIP costs associated with OP-1 than bone-harvest procedures given that only 1, rather than 2, incisions are needed when comparing the former with the latter procedure. This offset could amount to between $0.3 million to $0.7 million annually.
No data on the cost-effectiveness of OP-1 is available.
PMCID: PMC3382627  PMID: 23074475
6.  The Role of the Orthopaedic Surgeon 
Treatment for patients with vertebral compression fractures (VCFs) should address pain and mobility, and aim to prevent further fractures. Restoration of vertebral height to improve the spinal deformity is also of primary importance. Traditionally, osteoporosis-induced VCFs have been treated with bed rest, narcotic analgesics, braces, and physical therapy. However, immobility is known to have a negative impact on muscle strength and bone mass and may cause serious general health complications, narcotics can worsen mood and mentation problems, and brace wear is not well tolerated by the elderly. These fractures have a considerable impact on quality of life, and although most of them heal, the height loss and deformity remain uncorrected. Vertebroplasty and balloon kyphoplasty are minimally invasive treatment options for VCFs. Kyphoplasty is designed to reduce and stabilise the fracture in a controlled way, to correct the spinal deformity and to provide immediate pain relief, mobility, and an improved quality of life. The main differences between balloon kyphoplasty and vertebroplasty are the greater potential of the kyphoplasty procedure to restore the vertebral height and kyphosis angle of the fractured vertebra and (although the clinical significance of this has not yet been demonstrated) its lower percentage of cement extravasation; the latter is related to lower injection pressures, and facilitated by a higher cement viscosity and by the cavity created in the fractured vertebrae.
Worldwide, over 95,000 VCFs in 75,000 patients have been treated with balloon kyphoplasty. Accordingly, the orthopaedic surgeon today plays a leading role in the “Fracture Unit”, not only on the therapeutic side, but also on the diagnostic side. The kyphoplasty kit can allow percutaneous bone biopsy, often very important in order to obtain a correct diagnosis. In order to justify resource allocation and patient selection for new osteoporotic fracture treatment technologies, it is also becoming increasingly important to determine the cost-effectiveness of treatments. In a recent study we highlighted why spine surgery is important in VCFs, comparing the efficacy and safety of kyphoplasty and of non-surgical management for the treatment of acute osteoporotic VCFs. Our aim was to test the hypothesis that kyphoplasty would result in greater improvement in quality of life with a better cost-effectiveness ratio at 24 months’ follow up. Between January 2005 and September 2008, we randomly assigned 60 patients with one fresh (< 6 weeks) painful osteoporotic VCF to undergo either percutaneous surgical treatment with Medtronic Kyphoplasty (Group A, n=32) or conservative treatment (Group B, n=28), preceded by 40 days of bed rest and followed by 40 days of hyperextension back brace wear (type C35). The baseline characteristics were similar in the two groups: the average age was 67 years and 7 months, min. 62 - max. 89 years, in Group A, and 66 years and 5 months, min. 64 - max. 78 years, in Group B. The fractured levels were T12=10, L1=11, L2=5, L3=6 in Group A and T12=7, L1=13, L2=5, L3=3 in Group B. According to the Magerl classification the VCFs in both groups were prevalently A1.2 (13 cases in A and 16 in B) and A1.3 (14 cases in A and 8 in B). In all cases standing lateral spinal radiographs were taken at baseline, 3 months, 6 months, 12 months and 24 months to evaluate vertebral kyphosis (VK) and regional kyphosis (RK). Vertebral kyphosis was measured from the superior endplate to the inferior endplate of the fractured vertebra. Regional kyphosis was measured from the inferior endplate of the intact adjacent distal vertebra to the superior endplate of the intact adjacent proximal vertebra. Pain was evaluated at baseline, 3 months, 6 months, 12 months and 24 months with the VAS pain scale. Each patient had a card to be used for recording medical and non-medical costs sustained in the course of the 24 months.
The primary endpoint was the difference, between the groups, in VK and VAS pain scale score changes from baseline to 3, 6, 12 and 24 months: the surgical treatment group always showed better results. Mean VK was 11.50 degrees at baseline, 6.50 degrees at 3 months, 6.37 degrees at 6 months, and 6.38 degrees at 12 and 24 months in Group A and 12.6 degrees at baseline, 10.50 degrees at 3 months, 10.70 degrees at 6 months, and 11.80 degrees at 12 and 24 months in Group B. The VAS pain score was 9 (baseline), 2 (3 mths), 1 (6 mths), 2 (12 and 24 mths) in Group A and 9 (baseline), 7 (3 mths), 4 (6 mths), 5 (12 and 24 mths) in Group B.
The secondary endpoint was the difference, between surgical and conservative treatments, in medical (hospitalisation, surgical procedure, convalescence and 24-months follow up) and non-medical costs sustained. Group A recorded higher hospitalisation costs (average 9 days, € 4551) than Group B (average 5 days, € 2681). For the surgically treated group there was also an additional surgical procedure cost (average € 4,483.09).
The convalescence was longer in Group B (average 95 days, medical costs: € 2018,59) than in Group A (average 15 days, medical costs: € 192,92). Obviously, non-medical costs were also higher in Group B (€ 3390,00) than in Group A (€ 210,00). Between 3 and 24 months we recorded three cases of back pain Group A and 17 in Group B, with an additional cost of € 47,53 in the first group and € 1319,56 in the second. Therefore, on the whole, the surgical treatment had an average cost of € 9484,54 while the conservative treatment had an average cost of € 9409,15. However it is important to underline that in the second group there was also another non-medical cost that is difficult to quantify: that of family caregiving, which corresponds to 1 person’s days of absence from work (average 14 days, min. 5, max. 22).
The cost-effectiveness relationship becomes even better for the surgically treated group if we analyse the complications. In the first group we recorded seven asymptomatic minor complications (3 cases of vein leakage and 4 of intradiscal leakage) that did not generate supplementary medical or non-medical costs; instead, in the second group we recorded 13 complications (6 cases of decubitus ulcers and 7 cases of bronchitis) generating an additional cost of ⇔ 4325. Therefore, this study confirmed that kyphoplasty may today be the gold standard in the treatment of fresh osteoporotic VCFs. Accordingly, orthopaedic surgeon is destined to play an ever more important role within a superspecialist team.
PMCID: PMC3213845
7.  Is DBM Beneficial for the Enhancement of Bony Consolidation in Distraction Osteogenesis? A Randomized Controlled Trial 
BioMed Research International  2015;2015:281738.
The aim of the present study was to compare the radiographic and clinical outcomes of DBM injection and conventional treatment during tibial lengthening over an intramedullary nail in adult patients with short stature. Twenty-nine patients were randomized to receive DBM injection (n = 14) or conventional treatment without any injection (n = 15) and evaluated. The outcome was measured on the basis of the pixel value ratio (PVR) in the digital radiographs during the consolidation period; healing index; clinical assessment; and the rate of complications. In the DBM group, the mean PVR of 1 (mineral density of the callus is comparable to the adjacent bone) was reached by 40 weeks in anterior and medial cortices which was significantly different than that in the control group (P = 0.03 for anterior cortex; P = 0.04 for medial cortex). The average healing index in the DBM group was 39.8 ± 5.3 days/cm compared to 44.3 ± 5.8 days/cm in the control group (P = 0.05). There were no significant differences in clinical outcomes (P = 0.23) and functional status (P = 0.47) including complications (P = 0.72) between two groups. In this randomized clinical trial, injection of DBM at the time of initial operation enhanced consolidation of regenerate callus without interfering with clinical outcomes compared to that with conventional treatment.
doi:10.1155/2015/281738
PMCID: PMC4326219
8.  Outcome analysis of retrograde nailing and less invasive stabilization system in distal femoral fractures: A retrospective analysis 
Indian Journal of Orthopaedics  2011;45(3):243-250.
Background:
Two major therapeutic principles can be employed for the treatment of distal femoral fractures: retrograde intramedullary (IM) nailing (RN) or less invasive stabilization on system (LISS). Both operative stabilizing systems follow the principle of biological osteosynthesis. IM nailing protects the soft-tissue envelope due to its minimally invasive approach and closed reduction techniques better than distal femoral locked plating. The purpose of this study was to evaluate and compare outcome of distal femur fracture stabilization using RN or LISS techniques.
Materials and Methods:
In a retrospective study from 2003 to 2008, we analyzed 115 patients with distal femur fracture who had been treated by retrograde IM nailing (59 patients) or LISS plating (56 patients). In the two cohort groups, mean age was 54 years (17–89 years). Mechanism of injury was high energy impact in 57% (53% RN, 67% LISS) and low-energy injury in 43% (47% RN, 33% LISS), respectively. Fractures were classified according to AO classification: there were 52 type A fractures (RN 31, LISS 21) and 63 type C fractures (RN 28, LISS 35); 32% (RN) and 56% (LISS) were open and 68% (RN) and 44% (LISS) were closed fractures, respectively. Functional and radiological outcome was assessed.
Results:
Clinical and radiographic evaluation demonstrated osseous healing within 6 months following RN and following LISS plating in over 90% of patients. However, no statistically significant differences were found for the parameters time to osseous healing, rate of nonunion, and postoperative complications. The following complications were treated: hematoma formation (one patient RN and three patients LISS), superficial infection (one patient RN and three patients LISS), deep infection (2 patients LISS). Additional secondary bone grafting for successful healing 3 months after the primary operation was required in four patients in the RN (7% of patients) and six in the LISS group (10% of patients). Accumulative result of functional outcome using the Knee and Osteoarthritis Outcome (KOOS) score demonstrated in type A fractures a score of 263 (RN) and 260 (LISS), and in type C fractures 257 (RN) and 218 (LISS). Differences between groups for type A were statistically insignificant, statistical analysis for type C fractures between the two groups are not possible, since in type C2 and C3 fractures only LISS plating was performed.
Conclusion:
Both retrograde IM nailing and angular stable plating are adequate treatment options for distal femur fractures. Locked plating can be used for all distal femur fractures including complex type C fractures, periprosthetic fractures, as well as osteoporotic fractures. IM nailing provides favorable stability and can be successfully implanted in bilateral or multisegmental fractures of the lower extremity as well as in extra-articular fractures. However, both systems require precise preoperative planning and advanced surgical experience to reduce the risk of revision surgery. Clinical outcome largely depends on surgical technique rather than on the choice of implant.
doi:10.4103/0019-5413.80043
PMCID: PMC3087226  PMID: 21559104
Distal femoral fractures; osteosynthesis; minimally invasive techniques; retrograde intramedullary nailing; angular stable plating
9.  Treatment of nontraumatic osteonecrosis of the femoral head using bone impaction grafting through a femoral neck window 
International Orthopaedics  2009;34(5):635-639.
Nontraumatic osteonecrosis of the femoral head (non-ONFH) is a disorder that can lead to femoral head collapse and the need for total hip replacement. Various head-preserving procedures have been used for this disease to avert the need for total hip replacement. These include various vascularised and nonvascularised bone grafting procedures. We examined the effect of bone-grafting through a window at the femoral head-neck junction known as the “light bulb” approach for the treatment of osteonecrosis of the femoral head with a combination of demineralised bone matrix (DBM) and auto-iliac bone. The study included 110 patients (138 hips; 41 females, 69 males; mean age 32.36 years, range 17–54 years) with stage IIA–IIIA nontraumatic avascular necrosis of the femoral head according to the system of the ARCO (Association Research Circulation Osseous). The bone grafting procedure is called “light bulb” procedure in which the diseased bone was replaced by a bone graft substitute (combination of DBM and auto-iliac bone).The outcome was determined by the changes in the Harris hip score, by progression in radiographic stages, and by the need for hip replacement. The mean follow-up was 25.37 months (range 7–42 months). All data were processed by a statistics analysis including Cox risk model analysis and Kaplan-Meier survival analysis. Pre- and postoperative evaluations showed that the mean Harris hip score increased from 62 to 79. Clinically, 94 of 138 hips (68%) were successful at the latest follow-up, and radiological improvement was noted in 100% of patients in stage IIA, 76.67% of patients in stage IIB and 50.96% of patients in stage IIC and IIIA cases. Excellent and good results according to the Harris score were obtained in 100% of cases in stage IIA, 93.33% in stage IIB and 59.62% in stages IIIA and IIC stage, with a survivorship of 85% in stages IIA and IIB and 60% in stage IIIA and IIC cases. Cox risk model analysis showed that the clinical success rate correlated with both pre-operation stage and the necrotic area of the femoral head. The complications included ectopic ossification, lateral femoral cutaneous nerve lesion and joint infection. This procedure may be effective at avoiding or forestalling the need for total hip replacement in young patients with early to intermediate stages of osteonecrosis of the femoral head. Therefore, it may be the treatment of choice particularly in nontraumatic osteonecrosis of the femoral head of pre-collapse stage with small and middle area (<30%, or the depth of collapse <2 mm).
doi:10.1007/s00264-009-0822-1
PMCID: PMC2903158  PMID: 19529935
10.  The Effect of Poloxamer 407-Based Hydrogel on the Osteoinductivity of Demineralized Bone Matrix 
Clinics in Orthopedic Surgery  2014;6(4):455-461.
Background
Demineralized bone matrix (DBM) is used for bone healing due to its osteoinductivity, but it requires a carrier for clinical application. Here, we report the effects on the osteoinductivity of DBM by use of a poloxamer 407-based hydrogel as the carrier, compared to sterile water.
Methods
DBM-W and DBM-H represent 27 wt% of DBM with sterile water and DBM with a poloxamer 407-based hydrogel, respectively. Both of the compositions were applied to human mesenchymal stem cell (MSC) cultures, and monitored for alkaline phosphatase (ALP) staining and ALP activity. Six 10-week-old athymic nude rats were used for abdominal muscle grafting with either DBM-W or DBM-H, and were tested by plane radiography, microfocus X-ray computed tomography (CT), and decalcified histology to evaluate ectopic bone formation.
Results
The DBM-W group showed stronger ALP staining at 7, 14, and 21 days of treatment, and significantly higher ALP activity at 7 and 14 days of treatment, compared to the DBM-H group. Plane radiography could not confirm the radio-opaque lesions in the rat ectopic bone formulation model. However, ectopic bone formation was observed in both groups by micro-CT. Compared to the DBM-H group, the DBM-W group showed higher bone volume, percent bone volume and trabecular number, and the difference in percent bone volume was statistically significant. Decalcified histology found bony tissue with lamellation in both groups.
Conclusions
Our results suggest that poloxamer 407-based hydrogel has efficacy as a DBM carrier since it shows ectopic bone formation, but its effects on the quality and quantity of osteoblastic differentiation in rat abdominal ectopic bone and MSC are considered negative.
doi:10.4055/cios.2014.6.4.455
PMCID: PMC4233226  PMID: 25436071
Demineralized bone matrix; Osteoinductivity; Carrier; Poloxamer 407-based hydrogel
11.  Internal femoral osteosynthesis after external fixation in multiple-trauma patients 
Abstract
In this study the authors evaluate the results of internal synthesis of femoral fractures in polytraumatised patients initially treated by external fixation (EF). From January 2002 to December 2005, 39 femurs in 37 polytraumatised patients (average age 34.2 years, range 18-44) with closed fractures and an ISS>20 were initially treated with EF. There were three groups: Group A, 13 cases when conversion to internal osteosynthesis occurred after 4-7 days (average 5.6 days); Group B, 11 cases with a 4-6-month interval before internal osteosynthesis, and after investigation using MRI and scintigraphy with labelled leucocytes; Group C, the remaining cases treated definitively with EF. Time of healing, lower limb function, time of return to previous activities and short and long-term complications were evaluated at the follow-up. The average time of follow-up was 23 months. In Group A the time of bone healing was 123 days; there were no events of embolism but one case of pseudoarthrosis and one case of instrument failure. In Group B the time of bone healing was 274 days, with one case of pseudoarthrosis and one case of deep infection. In Group C the average healing time was 193 days, with 3 cases of screw (half-pin) osteolysis. Functional recovery was delayed by the presence of other fractures. EF is a simple, quick and safe procedure to stabilise fractures in polytraumatised patients. According to damage control orthopaedic (DCO) concepts, it is possible to replace EF with internal synthesis after an interval as this reduces the risks of internal osteosynthesis when performed in the emergency period. EF can also be maintained as definitive treatment but should a change to internal synthesis be needed, it is possible to do it safely after excluding bone infection.
doi:10.1007/s11751-007-0012-x
PMCID: PMC2321719  PMID: 18427913
Femoral fractures; Damage control orthopaedics; Internal femoral osteosynthesis; External fixation
12.  Internal femoral osteosynthesis after external fixation in multiple-trauma patients 
Abstract
In this study the authors evaluate the results of internal synthesis of femoral fractures in polytraumatised patients initially treated by external fixation (EF). From January 2002 to December 2005, 39 femurs in 37 polytraumatised patients (average age 34.2 years, range 18-44) with closed fractures and an ISS>20 were initially treated with EF. There were three groups: Group A, 13 cases when conversion to internal osteosynthesis occurred after 4-7 days (average 5.6 days); Group B, 11 cases with a 4-6-month interval before internal osteosynthesis, and after investigation using MRI and scintigraphy with labelled leucocytes; Group C, the remaining cases treated definitively with EF. Time of healing, lower limb function, time of return to previous activities and short and long-term complications were evaluated at the follow-up. The average time of follow-up was 23 months. In Group A the time of bone healing was 123 days; there were no events of embolism but one case of pseudoarthrosis and one case of instrument failure. In Group B the time of bone healing was 274 days, with one case of pseudoarthrosis and one case of deep infection. In Group C the average healing time was 193 days, with 3 cases of screw (half-pin) osteolysis. Functional recovery was delayed by the presence of other fractures. EF is a simple, quick and safe procedure to stabilise fractures in polytraumatised patients. According to damage control orthopaedic (DCO) concepts, it is possible to replace EF with internal synthesis after an interval as this reduces the risks of internal osteosynthesis when performed in the emergency period. EF can also be maintained as definitive treatment but should a change to internal synthesis be needed, it is possible to do it safely after excluding bone infection.
doi:10.1007/s11751-007-0012-x
PMCID: PMC2321719  PMID: 18427913
Femoral fractures; Damage control orthopaedics; Internal femoral osteosynthesis; External fixation
13.  The Fracture Unit Model. A Model for Implementation in Italy: “Multidisciplinary Approach for the Prevention and Treatment of Osteoporotic Vertebral Compression Fractures: VCF Unit” 
Reduced BMD is a risk factor for vertebral fractures (VFs). Every one SD increase in BMD is associated with a 2- to 2.5-fold increase in the risk of VFs. The presence of a previous fracture, vertebral or of other districts, is another important predictor of an increased risk of future fractures, independently of the association between BMD and fracture risk. Thus, the presence of both a low BMD and a previous fracture dramatically increases fracture risk. The definition of osteopo-rotic VFs has undergone considerable variations over the years, going from initial clinical sign of OP, through the now superseded definition of VFs as a disease, to a complication of OP resulting from bone fragility. The prevalence of VFs increases with age in both sexes, and it is calculated that at the age of 80 years, 37% of Caucasian women will have at least one radiographically evident VF. It has been estimated, again in Caucasian women, that the percentage incidence of fractures is 0.5% in those aged 50-55 years, 1.4% in those aged 65-69 years, and over 2% in women older than 75. However, two factors prevent an accurate assessment of the epidemiology of VFs. First, most VFs escape clinical diagnosis. Second, the absence of a “gold standard” radiographic definition of VFs has given rise to different ways of defining these lesions. VFs are rarely a cause of mortality, but they are associated with increased impairment of general conditions. Recurrent VFs have irreversible clinical consequences, such as reduction of height and chronic vertebral pain, which provoke an intensification of the pain and a greater degree of disability due to accentuation of kyphosis. The presence of VFs and kyphosis leads to a reduced thoracic volume and, consequently, to a loss of lung volume, in some cases severe enough to result in respiratory insufficiency. The consequences of the intense pain are: reduced range of motion, loss of balance, slowed gait and greater difficulty carrying out normal daily activities. In rare cases, lower limb pain and weakness may appear, caused by compression of the spinal medulla by the deformed vertebral body. The main aim of treatment is to restore the patient to his/her pre-trauma levels of functioning. This can be achieved through recourse to mini-invasive percutaneous techniques, vertebroplasty and kyphoplasty, with the aim of reducing the pain caused by osteo-porotic vertebral compression fractures, of preventing progression of the vertebral collapse and of rapidly re-establishing functional activity. Most fracture patients are discharged without undergoing a thorough bone metabolism assessment that could identify the causal factor of the fracture. In a high percentage (up to 95%) of patients with recent fractures, BMD is not measured and, therefore, a diagnosis of OP is not made. Consequently, these patients are not prescribed drugs capable of effectively reducing the risk of further fractures. Specialist orthopaedic centres need to introduce protocols designed to ensure application of the current procedures for diagnosing and treating OP.
On the basis of these considerations, we undertook to develop, in collaboration with the Department of Specialist Surgical Sciences of the University of Florence, the Orthopaedics and Traumatology Units 1, 2 and 3, the Recovery and Functional Re-education Unit, the Neurosurgery Unit, and the third Radiodiagnostics Unit of the Careggi Hospital in Floren-ce, a protocol that involves a range of specialists in assessing the introduction of variable, outcome-targeted medical therapies for osteoporotic patients submitted to kyphoplasty following fragility fractures of the vertebra. To choose the appropriate medical therapy, and to monitor its effects, the patients will be submitted to a series of clinical investigations. The “appropriate” therapy could include calcium and vitamin D supplementation, biphosphonates, SERMs, bone anabolic agents and combinations of drugs. The safety of the medical therapy and any adverse effects will be monitored at each follow-up visit through an appropriate questionnaire. This study aims to compare the outcomes of the group following a traditional pathway with those following a modified pathway (prescription of a targeted medical therapy), by means of metabolic, instrumental and functional tests performed at 2 months, 6 months, 1 year and 2 years. The general aim of the study will be to evaluate the efficacy and safety of a modified versus a traditional pathway in the care of osteoporotic patients undergoing kyphoplasty for VFs. The primary endpoint of the study will be the percentage of successes in the modified compared with the traditional pathway group. Secondary endpoints will be: change in femoral and lumbar BMD, changes in biochemical markers of bone remodelling and quality of life, assessment of safety parameters: overall and symptomatic cement leakage, pulmonary embolism, spinal medulla compression, radicular pain, radiculopathies and assessment of total procedure-related, cement-related and access-related adverse events. The ultimate aim of the study will be to prepare guidelines for the management, in terms of metabolic diagnosis and relative medical therapy, of patients with OP complicated by VFs.
PMCID: PMC3213825
14.  Free vascularised fibular grafting with OsteoSet®2 demineralised bone matrix versus autograft for large osteonecrotic lesions of the femoral head 
International Orthopaedics  2009;35(4):475-481.
The aim of this study was to compare the safety and efficacy of OsteoSet®2 DBM with autologous cancellous bone in free vascularised fibular grafting for the treatment of large osteonecrotic lesions of the femoral head. Twenty-four patients (30 hips) with large osteonecrotic lesions of the femoral head (stage IIC in six hips, stage IIIC in 14, and stage IVC in ten, according to the classification system of Steinberg et al.) underwent free vascularised fibular grafting with OsteoSet®2 DBM. This group was retrospectively matched to a group of 24 patients (30 hips) who underwent free vascularised fibular grafting with autologous cancellous bone during the same time period according to the aetiology, stage, and size of the lesion and the mean preoperative Harris hip score. A prospective case-controlled study was then performed with a mean follow-up duration of 26 months. The results show no statistically significant differences between the two groups in overall clinical outcome or the radiographic assessment. Furthermore, no adverse events related to the use of the OsteoSet®2 DBM were observed. The results demonstrate that OsteoSet®2 DBM combined with autograft bone performs equally as well as that of autologous bone alone. Therefore, OsteoSet®2 DBM can be used as a safe and effective graft extender in free vascularised fibular grafting for large osteonecrotic lesions of the femoral head.
doi:10.1007/s00264-009-0915-x
PMCID: PMC3066329  PMID: 20012040
15.  Mesenchymal Stem Cells Facilitate Fracture Repair in an Alcohol-Induced Impaired Healing Model 
Journal of orthopaedic trauma  2012;26(12):712-718.
Objectives
Clinical studies have shown alcohol to be a risk factor for traumatic orthopaedic injuries and for nonunion. Data from animal studies suggest that alcohol exposure inhibits fracture healing. This report presents a novel rodent model of impaired fracture healing caused by repeated alcohol exposure. Using this model, we examined the regenerative effects of an intravenously administered population of isolated and expanded MSCs on fracture healing.
Methods
Bone marrow-derived MSC were isolated from transgenic Green Fluorescent Protein (GFP) C57BL/6 mice and culture expanded using a lineage depletion protocol. Adult wild-type C57BL/6 mice were subjected to a two-week binge alcohol exposure paradigm, (3 days during which they received daily intraperitoneal injections of a 20% alcohol/saline solution followed by a four-day rest period and another 3 consecutive day binge cycle. At completion of the second binge cycle, mice were subjected to a midshaft tibia fracture while intoxicated. Twenty-four hours following fracture, animals were administered an intravenous (IV) transplant of GFP-labeled MSC. Two weeks following fracture, animals were euthanized and injured tibiae were collected and subjected to biomechanical, histologic, and micro-computed tomography analysis.
Results
Pre-injury binge alcohol exposure resulted in a significant impairment in biomechanical strength and decrease in callus volume. MSC transplants restored both fracture callus volume (p<0.05) and biomechanical strength (p<0.05) in animals with alcohol-impaired healing. In vivo imaging demonstrated a time-dependent MSC migration to the fracture site.
Conclusions
These data suggest that a two-week binge alcohol exposure significantly impairs fracture healing in a murine tibia fracture model. IV-administered MSC were capable of specifically homing to the fracture site and of normalizing biomechanical, histologic, and microCT parameters of healing in animals exposed to alcohol. Understanding MSC recruitment patterns and functional contributions to fracture repair may lead to their use in patients with impaired fracture healing and nonunion.
doi:10.1097/BOT.0b013e3182724298
PMCID: PMC3645443  PMID: 23010646
16.  Flexible intramedullary nailing for unicameral cysts in children’s long bones 
Purpose
The purpose of this study was to evaluate the outcome of flexible intramedullary nailing for unicameral bone cysts in terms of function and osseous consolidation.
Methods
Twenty-two unicameral bone cysts in children’s long bones were treated by flexible intramedullary nailing. In 13 cases the bone cyst was diagnosed in a traumatic event leading to a pathologic fracture. Fifteen patients were referred to our clinic after failed conservative treatment. In 16 patients the cyst was located in the humerus, and in 6 patients in the femur. Mean duration of follow-up after surgery was 24 months.
Results
According to Capanna’s criteria healing was obtained in 20 cases with a mean time of 16 months. Sixteen cysts healed completely. Four lesions were classified as grade 2, meaning that residual radiolucencies were radiographically visible at the latest follow-up. Two recurrences of humeral cysts were seen at 16 and 18 months postoperatively. The complication rate was minimal.
Conclusion
Due to the immediate stabilization of the lesion aftercare becomes facile. This method allows prompt mobilization and early weight bearing without the necessity of a plaster cast. Further it prevents effectively the most common complication, a re-fracture or a pathologic fracture. Therefore we propose this surgical procedure as the treatment of choice for unicameral bone cysts in children’s long bones.
doi:10.1007/s11832-007-0018-4
PMCID: PMC2656717  PMID: 19308480
Unicameral bone cyst; Children; Long bones; Flexible intramedullary nailing; Decompression
17.  Surgical treatment of displaced intra-articular calcaneal fractures: is bone grafting necessary? 
Background
The aim of this retrospective study was to determine the need for bone grafting in the surgical treatment of displaced intra-articular calcaneal fractures. We reviewed 390 cases of displaced intra-articular calcaneal fractures treated with plate osteosynthesis with or without autologous iliac bone grafting, and compared outcomes and complications related to fracture stabilization.
Materials and methods
Three hundred ninety patients with displaced intra-articular calcaneal fractures that were treated with plate osteosynthesis from December 2002 to December 2010 were reviewed. Two hundred two patients (group A) were treated by osteosynthesis with autologous bone grafting, and 188 patients (group B) were treated by osteosynthesis without bone grafting. One hundred eighty-one patients with an AO type 73-C1 fracture (Sanders type II), 182 patients with an AO type 73-C2 fracture (Sanders type III), and 27 patients with an AO type 73-C3 fracture (Sanders type IV) were included in this study. Bohler’s angle, the crucial angle of Gissane, and calcaneal height in the immediate postoperative period and at the 2-year follow-up were compared. Any change in the subtalar joint status was documented and analyzed. The final outcomes of all patients were evaluated by the AOFAS Ankle–Hindfoot Scale and compared in both groups.
Results
The mean full weight-bearing time in group A (with bone grafting) was significantly lower (median 6.2 months, range 2.8–9.2 months) than that in group B (without bone grafting; median 9.8 months, range 6.8–12.2 months). The immediate-postoperative Bohler’s angle and that at the 2-year follow-up were significantly higher in group A. The loss of Bohler’s angle after 2 years was significantly lower in group A (mean 3.5°; 95 % CI 0.8°–6.2°) than in group B (mean 6.2°; 95 % CI 1.0°–11.2°). The average change in the crucial angle and the average change in calcaneal height were not statistically significant for either group. The infection rate in the bone grafting group was higher, though statistically insignificantly so, than in the nongrafting group (8.3 vs. 6.3 %). No significant difference was found between the groups in terms of the rates of good reduction, postoperative osteoarthritis, and subtalar fusion. Regarding the efficacy outcomes, the mean AOFAS score was lower (mean 76.4 points; 95 % CI 65.8–82.9 points) in group A than in group B (mean, 81.6 points; 95 % CI, 72.3–88.8 points), but this difference was not significant (p > 0.05).
Conclusions
Bohler’s angle showed improved restoration and the patients returned to full weight-bearing earlier when bone grafting was used in the treatment of intra-articular calcaneal fracture. However, the functional outcomes and complication rates of both groups were similar.
doi:10.1007/s10195-013-0246-y
PMCID: PMC3828503  PMID: 23670493
Calcaneus; Displaced intra-articular fractures; Bone graft
18.  The Application of Closed Reduction Internal Fixation and Iliac Bone Block Grafting in the Treatment of Acute Displaced Femoral Neck Fractures 
PLoS ONE  2013;8(9):e75479.
Objective
This study aimed to evaluate the preliminary clinical and radiographic outcomes of acute displaced femoral neck fracture treated by closed reduction and internal fixation (CRIF) with free iliac bone block grafting with comparison to a routine protocol of CRIF without bone grafting.
Methods
From December 2008 to February 2010, 220 adult patients with acute displaced femoral neck fractures were enrolled in this study. In study group, there were 124 patients (57 males, 67 females) with a mean age of 44.8 years (range, 20-64 years). There were 70 transcervical fractures and 54 subcapital fractures. The patients were treated by CRIF and free iliac bone block grafting. The control group consisted of 96 adult patients (46 males, 50 females) with a mean age of 46.3 years (range, 23-64 years). There were 61 transcervical fractures and 35 subcapital fractures. The patients in control group were treated by CRIF without bone grafting.
Results
In study group, 112 patients were followed up for an average of 27.4 months (range, 24-34 months). All fractures healed within 5 months. However, 10 patients presented AVN of the femoral heads. The mean Harris score was 88.6 (range, 41-100). In control group, 68 patients were followed up for an average of 31.2 months (range, 24-42 months). The rates of AVN of the femoral head and fracture nonunion in control group were 26.5% (18/68) and 16.2% (11/68), respectively, significantly higher than those in study group (both P<0.05). The mean Harris score in control group was 83.8 (41–100), significantly lower than that in study group (P<0.05).
Conclusion
Acute displaced femoral neck fractures can be treated by CRIF and free iliac bone block grafting in a minimally invasive manner. This technique can guarantee uneventful fracture healing and significantly reduce the rate of femoral head osteonecrosis.
doi:10.1371/journal.pone.0075479
PMCID: PMC3769404  PMID: 24040414
19.  Repair of long bone defects with demineralized bone matrix and autogenous bone composite 
Indian Journal of Orthopaedics  2011;45(3):226-230.
Background:
Repair of diaphyseal bone defects is a challenging problem for orthopedic surgeons. In large bone defects the quantity of harvested autogenous bone may not be sufficient to fill the gap and then the use of synthetic or allogenic grafts along with autogenous bone becomes mandatory to achieve compact filling. Finding the optimal graft mixture for treatment of large diaphyseal defects is an important goal in contemporary orthopedics and this was the main focus of this study. The aim of this study is to investigate the efficacy of demineralized bone matrix (DBM) and autogenous cancellous bone (ACB) graft composite in a rabbit bilateral ulna segmental defect model.
Materials and Methods:
Twenty-seven adult female rabbits were divided into five groups. A two-centimeter piece of long bone on the midshaft of the ulna was osteotomized and removed from the rabbits’ forearms. In group 1 (n=7) the defects were treated with ACB, in group 2 (n=7) with DBM, and in group 3 (n=7) with ACB and DBM in the ratio of 1:1. Groups 4 and 5, with three rabbits in each group, were the negative and positive controls, respectively. Twelve weeks after implantation the rabbits were sacrificed and union was evaluated with radiograph (Faxitron), dual-energy x-ray absorptiometry (DEXA), and histological methods (decalcified sectioning).
Results:
Union rates and the volume of new bone in the different groups were as follows: group 1 - 92.8% union and 78.6% new bone; group 2 - 72.2% union and 63.6% new bone; and group 3 - 100% union and 100% new bone. DEXA results (bone mineral density [BMD]) were as follows: group 1 - 0.164 g/cm2, group 2 - 0.138 g/cm2, and group 3 - 0.194 g/cm2.
Conclusions:
DBM serves as a graft extender or enhancer for autogenous graft and decreases the need of autogenous bone graft in the treatment of bone defects. In this study, the DBM and ACB composite facilitated the healing process. The union rate was better with the combination than with the use of any one of these grafts alone.
doi:10.4103/0019-5413.80040
PMCID: PMC3087223  PMID: 21559101
Bone healing; bone defect; bone graft; fracture union
20.  Minimally Invasive Plate Osteosynthesis for Open Fractures of the Proximal Tibia 
Clinics in Orthopedic Surgery  2012;4(4):313-320.
Background
Relatively few studies have addressed plate osteosynthesis for open proximal tibial fractures by now. The purpose of this study was to assess the results of minimally invasive plate osteosynthesis (MIPO) for open fractures of the proximal tibia.
Methods
Thirty-four patients with an open proximal tibial fracture were treated by MIPO. Thirty of these, who followed for over 1 year, constituted the subject of this retrospective study. According to the AO Foundation and Orthopaedic Trauma Association (AO-OTA) classification, there were 3 patients of type 41-C, 6 of type 42-A, 8 of type 42-B, and 13 of type 42-C. In terms of the Gustilo and Anderson's open fracture grading system, 11 patients were of grade I, 6 were of grade II, and 13 were of grade III (III-A, 6; III-B, 6; III-C, 1). After thorough debridement and wound cleansing, when necessary, a soft tissue flap was placed. Primary MIPO (simultaneous plate fixation with soft tissue procedures) was performed in 18 patients, and staged MIPO (temporary external fixation followed by soft tissue procedures and subsequent conversion to plate fixation after soft tissue healing) was performed in 12 patients. Results were assessed according to the achievement and time to union, complications (including infections), and function of the knee joint using Knee Society scores. Statistical analysis was performed to identify factors influencing results.
Results
Primary union was achieved by 24 of the 30 study subjects. Early bone grafting was performed in 6 cases with a massive initial bone defect expected to result in non-union. No patient had malalignment greater than 10°. The mean Knee Society score was 88.7 at final follow-up visits, 23 patients achieved an excellent result, and 7 a good result. There were 3 superficial and 5 deep infections, but none required early implant removal. Functional results were similar for primary and staged MIPO (p = 0.113). Fracture pattern (p = 0.089) and open fracture grade (p = 0.079) were not found to influence the results.
Conclusions
If soft tissue coverage is adequately performed, MIPO could be regarded as an acceptable method for the treatment of open proximal tibial fracture.
doi:10.4055/cios.2012.4.4.313
PMCID: PMC3504697  PMID: 23205242
Proximal; Tibia; Open fracture; Minimally invasive surgical procedure; Plate; Osteosynthesis
21.  Safety of autologous bone marrow aspiration concentrate transplantation: initial experiences in 101 patients 
Orthopedic Reviews  2009;1(2):e32.
The clinical application of cellular based therapies with ex vivo cultivation for the treatment of diseases of the musculoskeletal system has until now been limited. In particular, the advanced laboratory and technical effort necessary, regulatory issues as well as high costs are major obstacles. On the other hand, newly developed cell therapy systems permit intra-operative enrichment and application of mesenchymal and progenitor stem cells from bone marrow aspirate concentrate (BMAC) in one single operative session. The objective of the present clinical surveillance study was to evaluate new bone formation after the application of BMAC as well as to record any possible therapy-specific complications
For this purpose, the clinical-radiological progress of a total of 101 patients with various bone healing disturbances was documented (surveillance study). The study included 37 necrosis of the head of the femur, 32 avascular necroses/bone marrow edema of other localization, 12 non-unions, 20 other defects. The application of BMAC was performed in the presence of osteonecrosis via a local injection as part of a core decompression (n=72) or by the local adsorption of intra-operative cellular bone substitution material (scaffold) incubated with BMAC during osteosynthesis (n=17) or in further surgery (n=12).
After an average of 14 months (2–24 months), the patients were re-examined clinically and radiologically and interviewed. Further surgery was necessary in 2 patients within the follow-up period. These were due to a progression of a collapsed head of the femur with initial necrosis in ARCO Stage III, as well as inadequate new bone formation with secondary loss of correction after periprosthetic femoral fracture. The latter healed after repeated osteosynthesis plus BMAC application without any consequences. Other than these 2 patients, no further complications were observed. In particular, no infections, no excessive new bone formation, no induction of tumor formation, as well as no morbidity due to the bone marrow aspiration from the iliac crest were seen.
There were no specific complications within the short follow-up period and a simple intra-operative use of the system for different forms of bone loss could be demonstrated. In the authors' opinion, the on-site preparation of the bone marrow cells within the operating theater eliminates the specific risk of ex vivo cell proliferation and has a safety advantage in the use of autologous cell therapy for bone regeneration. Additional studies should be completed to determine efficacy.
doi:10.4081/or.2009.e32
PMCID: PMC3143993  PMID: 21808691
bone marrow aspirate concentrate application.
22.  Two-stage procedure protocol for minimally invasive plate osteosynthesis technique in the treatment of the complex pilon fracture 
International Orthopaedics  2011;36(4):833-837.
Purpose
Here we introduce a two-stage procedure protocol for minimally invasive plate osteosynthesis (MIPO) to treat complex pilon fractures and evaluate surgical wound healing and infection rates after this method was applied in clinical practice.
Method
This is a retrospective study design. The protocol consisted of immediate (within eight to 24 hours) open reduction and internal fixation of the fibula, using a fibular plate or one third tubular plate and application of an external fixator spanning the ankle joint. Patients were discharged after initial stabilisation and revaluated approximately ten to 14 days after discharge. Formal open reconstruction of the articular surface using MIPO depended on whether soft tissue swelling had lessened. Artificial bone was then injected into the defect rather than open surgery. Objective evaluation criteria were wound infection rates. Objective criteria (amount of post-traumatic arthritis, range of ankle movement, number of arthrodeses) and subjective criteria (pain, swelling, restriction of work or leisure activities) were identified via chart and radiograph reviews, patient interviews and physical examination.
Results
Twenty-nine patients, each with one pilon fracture were included. First-stage operations were performed from eight hours to seven days after injury, depending on whether the fracture was open or not. Average time from external fixation to open reduction and revision was one month (range 24–38 days); average time for the second-stage operation was 58 (range 45–110) minutes; average amount of haemorrhage was 400 (range 150–560) ml; average time of follow-up was 24 months and average time of healing was 6.7 (range five to 11.5) months after the second stage. There was no superficial or deep infection or wound-healing problem. All patients had normal functioning ankle joints.
Conclusion
Application of the two-stage procedure protocol with MIPO seems to play a key role in reducing infection rates associated with open reduction and internal fixation of pilon fractures. Its effectiveness in closed and open fractures will be further tested by a late randomised controlled study.
doi:10.1007/s00264-011-1434-0
PMCID: PMC3311799  PMID: 22183151
23.  Clinical and radiographic evaluation of demineralized bone matrix (grafton) as a bone graft material in the treatment of human periodontal intraosseous defects 
Purpose:
The purpose of this clinical trial was to evaluate the efficacy of demineralized bone matrix (DBM) as a bone graft material in the treatment of human intrabony periodontal defects as compared with control defects treated by open flap debridement (OFD) alone.
Materials and Methods:
A controlled clinical trial was carried out for a period of 9 months in 11 patients (4 males and 7 females) with an age group of 25-50 years, contributing to a total of 30 defects. The selected defects were then randomly divided in to experimental sites (OFD + DBM) and control sites (OFD alone). Probing depth, clinical attachment levels and position of the gingival margin were recorded at baseline 3, 6 and 9 months post-operatively. Standardized radiographs (parallel technique) were also documented at these recall intervals.
Results:
On completion of 9 months, the mean percentage of probing depth reduction achieved in the experimental sites and control sites was 61.70%, 23.86% respectively. The mean percentage of clinical attachment level gain was 61.34% and 19.37% in the experimental and control sites respectively. In the experimental sites recession was observed to a lesser extent.
Conclusion:
The use of DBM was more effective than OFD in improving clinical parameters and radiographic bone fill as shown in the present study. However, there is a need for further long term studies.
doi:10.4103/0972-124X.118323
PMCID: PMC3800414  PMID: 24174731
Allografts; demineralized bone matrix; osteoinduction; regeneration
24.  Prospective blind comparative clinical study of two point fixation of zygomatic complex fracture using wire and mini plates 
Background
The zygomatic maxillary complex (ZMC) fractures are one of the most frequent injuries of the facial skeleton due to its position and facial contour. Assaults, road traffic accidents and falls are the principal etiologic factors that may cause fractures of zygomatic bone. The different fixation methods are applied to treat the zygomatic bone fractures, with many more classifications which have been described in the literature for the ease of management. The type of the fracture, its severity and associated facial fractures usually interferes the treatment modality.
Purpose of study
The aim of this paper is to show the results of 18yrs prospective blind comparative study using wire and plate osteosynthesis which needed open reduction and internal fixation involving Type II to Type IV Spissel and Schroll ZMC fractures.
Materials and methods
Total 80 cases included in the study out of 1780 ZMC cases which were treated using wire and plate osteosynthesis over a period of 18 yrs, involving only Type II to Type IV Spissel and Schroll ZMC fractures. Other types excluded from study to prevent observer bias. All the fixations carried out through Standard Dingman's incision using stainless steel 26 gauze wire and titanium 1.5 mm mini plate system under general anesthesia by single maxillofacial surgeon and evaluated by another maxillofacial surgeon who is blinded for surgical procedure after 2 and 4 wks of follow-up for facial symmetry, wound healing, functional assessment (mouth opening, diplopia), and sensory disturbance. All the data tabulated in Excel software (Microsoft) for statistical analysis. P-value calculated to know the Significance of treatment modality in all aspects.
Results
Result shows no significant p-values indicating both the operating techniques are equally efficient in the surgical management of ZMC fracture.
Conclusion
Osteosynthesis by mini plates is simple, logical and effective treatment compared to wire osteosynthesis in regard to stability of fracture fragments. Wire osteosynthesis will be helpful in emergency surgeries or where the mini plates are not available. Even though the wire osteosynthesis is economical compared to mini plate fixation; but the time and skill is required for fixation of wires.
doi:10.1186/1746-160X-8-7
PMCID: PMC3342088  PMID: 22390884
Zygomatic maxillary complex (ZMC); Internal fixation; Wire osteosynthesis; Mini plate osteosynthesis; Comparison of fixation
25.  Treatment of the humeral shaft fractures - minimally invasive osteosynthesis with bridge plate versus conservative treatment with functional brace: study protocol for a randomised controlled trial 
Trials  2013;14:246.
Background
Humeral shaft fractures account for 1 to 3% of all fractures in adults and for 20% of all humeral fractures. Non-operative treatment is still the standard treatment of isolated humeral shaft fractures, although this method can present unsatisfactory results. Surgical treatment is reserved for specific conditions. Modern concepts of internal fixation of long bone shaft fractures advocate relative stabilisation techniques with no harm to fracture zone. Recently described, minimally invasive bridge plate osteosynthesis has been shown to be a secure technique with good results for treating humeral shaft fractures. There is no good quality evidence advocating which method is more effective. This randomised controlled trial will be performed to investigate the effectiveness of surgical treatment of humeral shaft fractures with bridge plating in comparison with conservative treatment with functional brace.
Methods/Design
This randomised clinical trial aims to include 110 patients with humeral shaft fractures who will be allocated after randomisation to one of the two groups: bridge plate or functional brace. Surgical treatment will be performed according to technique described by Livani and Belangero using a narrow DCP plate. Non-operative management will consist of a functional brace for 6 weeks or until fracture consolidation. All patients will be included in the same rehabilitation program and will be followed up for 1 year after intervention. The primary outcome will be the DASH score after 6 months of intervention. As secondary outcomes, we will assess SF-36 questionnaire, treatment complications, Constant score, pain (Visual Analogue Scale) and radiographs.
Discussion
According to current evidence shown in a recent systematic review, this study is one of the first randomised controlled trials designed to compare two methods to treat humeral shaft fractures (functional brace and bridge plate surgery).
Trial registration
Current Controlled Trials: ISRCTN24835397
doi:10.1186/1745-6215-14-246
PMCID: PMC3750574  PMID: 23924198
Humeral fractures; Immobilisation; Fracture fixation; Internal; Orthopaedic fixation devices

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