Systemic Administration of PTH Supports Vascularization in Segmental Bone Defects Filled with Ceramic-Based Bone Graft Substitute.

Non-unions continue to present a challenge to trauma surgeons, as current treatment options are limited, duration of treatment is long, and the outcome often unsatisfactory. Additionally, standard treatment with autologous bone grafts is associated with comorbidity at the donor site. Therefore, alternatives to autologous bone grafts and further therapeutic strategies to improve on the outcome and reduce cost for care providers are desirable. In this study in Sprague-Dawley rats we employed a recently established sequential defect model, which provides a platform to test new potential therapeutic strategies on non-unions while gaining mechanistic insight into their actions. The effects of a combinatorial treatment of a bone graft substitute (HACaS+G) implantation and systemic PTH administration was assessed by µ-CT, histological analysis, and bio-mechanical testing and compared to monotreatment and controls. Although neither PTH alone nor the combination of a bone graft substitute and PTH led to the formation of a stable union, our data demonstrate a clear osteoinductive and osteoconductive effect of the bone graft substitute. Additionally, PTH administration was shown to induce vascularization, both as a single adjuvant treatment and in combination with the bone graft substitute. Thus, systemic PTH administration is a potential synergistic co-treatment to bone graft substitutes.

Bioinformatic analysis and experimental identification of blood biomarkers for chronic nonunion.

BACKGROUND: Incomplete fracture healing may lead to chronic nonunion; thus, determining fracture healing is the primary issue in the clinical treatment. However, there are no validated early diagnostic biomarkers for assessing chronic nonunion. In this study, bioinformatics analysis combined with an experimental verification strategy was used to identify blood biomarkers for chronic nonunion. METHODS: First, differentially expressed genes in chronic nonunion were identified by microarray data analysis. Second, Dipsaci Radix (DR), a traditional Chinese medicine for fracture treatment, was used to screen the drug target genes. Third, the drug-disease network was determined, and biomarker genes were obtained. Finally, the potential blood biomarkers were verified by ELISA and qPCR methods. RESULTS: Fifty-five patients with open long bone fractures (39 healed and 16 nonunion) were enrolled in this study, and urgent surgical debridement and the severity of soft tissue injury had a significant effect on the prognosis of fracture. After the systems pharmacology analysis, six genes, including QPCT, CA1, LDHB, MMP9, UGCG, and HCAR2, were chosen for experimental validation. We found that all six genes in peripheral blood mononuclear cells (PBMCs) and serum were differentially expressed after injury, and five genes (QPCT, CA1, MMP9, UGCG, and HCAR2) were significantly lower in nonunion patients. Further, CA1, MMP9, and QPCT were markedly increased after DR treatment. CONCLUSION: CA1, MMP9, and QPCT are biomarkers of nonunion patients and DR treatment targets. However, HCAR2 and UGCG are biomarkers of nonunion patients but not DR treatment targets. Therefore, our findings may provide valuable information for nonunion diagnosis and DR treatment. TRIAL REGISTRATION: ISRCTN, ISRCTN13271153. Registered 05 April 2020-Retrospectively registered.

Electrical stimulation-based bone fracture treatment, if it works so well why do not more surgeons use it?

BACKGROUND: Electrical stimulation (EStim) has been proven to promote bone healing in experimental settings and has been used clinically for many years and yet it has not become a mainstream clinical treatment. METHODS: To better understand this discrepancy we reviewed 72 animal and 69 clinical studies published between 1978 and 2017, and separately asked 161 orthopedic surgeons worldwide about their awareness, experience, and acceptance of EStim for treating fracture patients. RESULTS: Of the 72 animal studies, 77% reported positive outcomes, and the most common model, bone, fracture type, and method of administering EStim were dog, tibia, large bone defects, and DC, respectively. Of the 69 clinical studies, 73% reported positive outcomes, and the most common bone treated, fracture type, and method of administration were tibia, delayed/non-unions, and PEMF, respectively. Of the 161 survey respondents, most (73%) were aware of the positive outcomes reported in the literature, yet only 32% used EStim in their patients. The most common fracture they treated was delayed/non-unions, and the greatest problems with EStim were high costs and inconsistent results. CONCLUSION: Despite their awareness of EStim's pro-fracture healing effects few orthopedic surgeons use it in their patients. Our review of the literature and survey indicate that this is due to confusion in the literature due to the great variation in methods reported, and the inconsistent results associated with this treatment approach. In spite of this surgeons seem to be open to using this treatment if advancements in the technology were able to provide an easy to use, cost-effective method to deliver EStim in their fracture patients.

Pulsed electromagnetic field (PEMF): A potential adjuvant treatment for infected nonunion.

Infected nonunion is still a challenge for orthopaedic surgeons. The goal of treatment is to eliminate infection and achieve bone union. Surgery is the only effective method currently. However, it is invasive and the results are still unsatisfactory. Therefore, seeking a noninvasive and effective method to resolve infected nonunion is necessary. Pulsed electromagnetic field (PEMF) has been used for the treatment of nonunion for more than 40 years. PEMF could promote bone formation at tissue, cell and subcellular levels. Furthermore, our study showed that PEMF had bactericidal effect. The hypothesis we proposed herein is that PEMF may be an adjuvant treatment for infected nonunion by controlling infection and inducing bone formation.

Role of isolated percutaneous autologous platelet concentrate in delayed union of long bones.

PURPOSE: The objective of this study is to evaluate the efficacy of percutaneous platelet concentrate (PC) injection in increasing the chances of attaining union in delayed union of long bones and to know whether the time taken for union decreases with use of PC. METHODS: Forty delayed unions (15-30 weeks old) were randomized into a study group in which autologous PC prepared by blood bank centrifuge was percutaneously injected at the fracture site under image intensifier after activation with 10% calcium gluconate and a control group where patients were observed over time. Follow-up was every 6 weeks till fracture union. At each follow-up visit clinical and radiological parameters of union were assessed. RESULTS: Percentage union was 78% (18/23) in PC group and 59% (10/17) in control group, respectively (p = 0.296). The mean time to fracture union treated with PC (15.33 ± 9.91 weeks) was not different from the control group (13.10 ± 7.21 weeks; p = 0.540). In the PC group union is seen in 12 weeks after PC injection in 60 per cent of the cases. CONCLUSION: Isolated percutaneous PC injection increases union rates in delayed union of long bones. The results were, however, not statistically significant but show high positive association. Further studies are required to recommend routine use of PC injection.

Treatment of aseptic tibial shaft non-union without bone defect.

Non-union is incomplete consolidation of a fracture, without effective formation of a uniting callus. Despite better understanding of the physiology of bone consolidation, management of tibial non-union remains a challenge for orthopedic surgeons. Several treatments have been developed in recent decades, and we now have a range of techniques, with indications based on type of non-union, prior treatments, available equipment, and the surgeon's experience. Firstly, there are surgical techniques such as osteo-periosteal decortication, cancellous iliac graft, or inter-tibiofibular graft. The decision to fix the non-union (or revise existing fixation) and choice of type of internal fixation depend on the stability of the fracture site. There are also non-operative biological and biochemical consolidation stimulation techniques: local injection of bone-marrow, platelet-rich plasma (PRP) or bone morphogenetic protein (BMP). Stimulation can also be physical, applying ultrasound or an electromagnetic field to the non-union site. Each technique may be used in isolation or association.

Carpal scaphoid non-union treatment: a retrospective trial comparing simple retrograde percutaneous screw fixation versus percutaneous screw fixation plus pulsed electromagnetic fields (Physiostim®).

BACKGROUND: The purpose of this retrospective comparative study was to assess whether a complementary treatment by pulsed electromagnetic field could increase the bone-healing rate of scaphoid non-union without SNAC (scaphoid non-union advanced collapse) treated by retrograde percutaneous screw fixation. CASE DESCRIPTION: Eighteen patients with scaphoid non-union were included in this retrospective study. The group 1 was made of nine cases (seven stage IIA and two stage IIB) of scaphoid non-union treated by retrograde percutaneous screw fixation and pulsed electromagnetic fields (Physiostim®). The group 2 was made of nine cases (six stage IIA and three stage IIB) treated by simple retrograde percutaneous screw fixation. RESULTS: With a 10-month follow-up in group 1 and a 9.5-month follow-up in group 2, there were three cases of non-union in group 1 and two cases in group 2. Regarding the type of non-union, there was one case among the stage IIB and four cases among the stage IIA. CLINICAL RELEVANCE: The results of the study did not show any interest in the use of pulsed electromagnetic field for the treatment of carpal scaphoid non-union. They should be dropped. LEVEL OF EVIDENCE: III.

Antibiotic-impregnated calcium phosphate cement as part of a comprehensive treatment for patients with established orthopaedic infection.

BACKGROUND: The treatment of established orthopaedic infection is challenging. While the main focus of treatment is wide surgical debridement, systemic and local antibiotic administration are important adjuvant therapies. Several reports have described the clinical use of antibiotic-impregnated calcium phosphate cement (CPC) to provide local antibiotic therapy for bone infections. However, these were all individual case reports, and no case series have been reported. We report a case series treated by a single surgeon using antibiotic-impregnated CPC as part of a comprehensive treatment plan in patients with established orthopaedic infection. METHODS: We enrolled 13 consecutive patients with osteomyelitis (n = 6) or infected non-union (n = 7). Implantation of antibiotic-impregnated CPC was performed to provide local antibiotic therapy as part of a comprehensive treatment plan that also included wide surgical debridement, systemic antibiotic therapy, and subsequent second-stage reconstruction surgery. We investigated the rate of successful infection eradication and systemic/local complications. The concentration of antibiotics in the surgical drainage fluids, blood, and recovered CPC (via elution into a phosphate-buffered saline bath) were measured. RESULTS: The mean follow-up period after surgery was 50.4 (range, 27-73) months. There were no cases of infection recurrence during follow-up. No systemic toxicity or local complications from the implantation of antibiotic-impregnated CPC were observed. The vancomycin concentration in the fluid from surgical drainage (n = 6) was 527.1 ± 363.9 µg/mL on postoperative day 1 and 224.5 ± 198.4 µg/mL on postoperative day 2. In patients who did not receive systemic vancomycin therapy (n = 3), the maximum serum vancomycin level was <0.8 µg/mL. In vitro vancomycin elution was observed from the CPC that was surgically retrieved (n = 2). CONCLUSIONS: Implantation of antibiotic-impregnated CPC is an option to provide local antibiotic therapy as part of a comprehensive treatment plan.

Bovine xenograft application for treatment of a metatarsal nonunion fracture in an alpaca (Vicugna pacos).

CASE HISTORY: A 15-year-old female huacaya alpaca (Vicugna pacos) was referred because of a non-weight-bearing lameness (4/4) in the left pelvic limb caused by a grade three open metatarsal fracture. The referring veterinarian treated the fracture with conservative management using bandages, but it progressively evolved to a non-union. CLINICAL FINDINGS AND DIAGNOSIS: Clinical examination revealed external wounds on the medial and lateral surfaces of the metatarsus. Radiographs confirmed an open, nonarticular, displaced, diaphyseal fracture of the left metatarsus. TREATMENT AND OUTCOME: Cancellous bone was sourced from bovine proximal and distal femur epiphyses, followed by a thermal shock procedure to achieve decellularisation, to produce a xenograft. Open reduction and internal fixation of the fracture using locking plates was performed. Alignment of the fracture fragments was corrected and the xenograft was placed at the debrided fracture site to stimulate and harness osteogenesis in situ. Clinical and radiographic follow-up was performed up to 40 weeks postoperatively. Clinical evaluations revealed that the alpaca gradually increased weight bearing following bandage removal 10 days after surgery. Serial radiographs showed correct alignment of the left metatarsus, progressive bone modelling and, complete bone union at 12 weeks. Ten months postoperatively the alpaca showed no signs of lameness and resumed normal activity. CLINICAL RELEVANCE: For management of a metatarsal non-union, a combination of bovine xenograft application and angular stable internal fixation progressed toward an excellent long-term recovery.

Cost effectiveness of tibial nonunion treatment: A comparison between rhBMP-7 and autologous bone graft in two Italian centres.

Current evidences show that recombinant human bone morphogenetic protein 7 (rhBMP-7, eptotermin alfa) can be considered an effective alternative to autologous bone graft (ABG) in the treatment of tibial nonunions. Few studies, so far, have analysed the costs of treating tibial nonunions with either rhBMP-7 or ABG and none of them has specifically considered the Italian situation. The aim of the present study was to capture, through observational retrospective methods, the direct medical costs associated with the treatment of tibial nonunions with rhBMP-7 or ABG in Italy and to compare the cost effectiveness of the two interventions. The secondary objective was to perform a cost-reimbursement analysis for hospitalisations associated with the two treatments. Data of 54 patients with indication for tibial nonunion were collected from existing data sources. Of these patients, 26 were treated with ABG and 28 with rhBMP-7. The study captured the direct medical costs for treating each tibial nonunion, considering both inpatient and outpatient care. The hospital reimbursement was calculated from discharge registries, based on diagnosis-related group (DRG) values. A subgroup of patients (n=30) was also interviewed to capture perceived health during the follow-up, and the quality-adjusted life years (QALYs) were subsequently computed. The two groups were similar for what concerns baseline characteristics. While the medical costs incurred during the hospitalisation associated with treatment were on average €3091.21 higher (P<0.001) in patients treated with rhBMP-7 (reflecting the product procurement costs), the costs incurred during the follow-up were on average €2344.45 higher (P=0.02) in patients treated with ABG. Considering all costs incurred from the treatment, there was a borderline statistical evidence (P=0.04) for a mean increase of €795.42, in the rhBMP-7 group. Furthermore, the study demonstrated that, without appropriate reimbursement, the hospital undergoes significant losses (P=0.003) when using rhBMP-7 instead of ABG. In contrast to these losses, in Italy, the average cost to achieve a successful outcome was €488.96 lower in patients treated with rhBMP-7 and, additionally, the cost per QALY gained was below the cost-utility threshold of $50,000.

Sonographically assisted percutaneous removal of screws in dynamization of the interlocking intramedullary nail.

OBJECTIVES: Dynamization is a method of removing the interlocking screw(s) farthest from the fracture site for improving healing in femoral and tibial fractures that show delayed healing after static interlocking nailing. We describe a simple sonographically assisted technique for percutaneous dynamization of deep-seated impalpable screws. METHODS: Between March 2001 and March 2005, 20 dynamization procedures were completed using the developed technique under the diagnosis of delayed healing or a nonunion at a mean of 4.8 months after index surgery. After adequately positioning the involved leg, the transducer was placed on the area of the inlet of the screw. Longitudinal and transverse sonographically scanned sections, used to show the head of the screw, were then marked on the skin where the two sections intersected. After this precise marking, a small incision on the mark allowed insertion of the screwdriver and easy percutaneous removal of the screw using only local anesthesia for pain control. RESULTS: We removed 31 screws: 9 proximal femoral screws, 20 distal femoral screws, and 2 proximal tibial screws. The mean depth of the screws was 3.4 cm. The mean operation times were 1.6 minutes for the sonographic examination and 3.5 minutes for removal of one screw. No infections or morbidities were caused by the procedure. CONCLUSIONS: Sonography is an effective tool for localizing a locked screw and facilitates percutaneous removal of screws under only local anesthesia for dynamization. This method needs no special instruments and reduces the time needed for dissecting the tissue and locating the screw.

Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study.

BACKGROUND: Pulsed electromagnetic field (PEMF) is reported to be an effective adjunct for the management of nonunion long-bone fractures. Most studies implement PEMF treatment after 6 months or longer of delayed union or nonunion following fracture treatment. Despite these variations in treatment, the early application of PEMF following a diagnosis of a postoperative delayed union has not been specifically analyzed. In this study, the outcomes of postoperative delayed union of long-bone fractures treated with an early application of PEMF were evaluated as compared with a sham-treated control group. METHODS: In this prospective, randomized controlled study, a total of 58 long-bone fracture patients, who presented with delayed union of between 16 weeks and 6 months, were randomly split into two groups and subjected to an early application of PEMF or sham treatment. Clinical and radiological assessments were performed to evaluate the healing status. Treatment efficacy was assessed at three month intervals. RESULTS: Patients in the PEMF group showed a higher rate of union than those in the control group after the first three months of treatment, but this difference failed to achieve statistical significance. At the end of the study, PEMF treatment conducted for an average of 4.8 months led to a success rate of 77.4%. This was significantly higher than the control, which had an average duration of 4.4 months and a success rate of 48.1%. The total time from operation to the end of the study was a mean of 9.6 months for patients in the PEMF group. CONCLUSIONS: Fracture patients treated with an early application of PEMF achieved a significantly increased rate of union and an overall reduced suffering time compared with patients that receive PEMF after the 6 months or more of delayed union, as described by others.

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than one atmosphere absolute (ATA) in a pressure vessel. This technology has been used to treat a variety of diseases and has been described as helping patients who have delayed healing or established non-union of bony fractures. This is an update of a Cochrane Review first published in 2005, and previously updated in 2008. OBJECTIVES: The aim of this review is to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of delayed bony healing and established non-union of bony fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2012), the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1946 to July Week 1 2012), EMBASE (1974 to 2012 July 16), CINAHL (1937 to 17 July 2012), the Database of Randomised Controlled Trials in Hyperbaric Medicine (accessed July 2012), the WHO International Clinical Trials Registry Platform (17 July 2012) and reference lists of articles. SELECTION CRITERIA: We aimed to include all randomised controlled trials comparing the clinical effects of HBOT with no HBOT (no treatment or sham) for healing of bony fractures and fracture non-unions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened electronic search results, and all three authors independently performed study selection. We planned independent data collection and risk of bias assessment by two authors using standardised forms. MAIN RESULTS: No trials met the inclusion criteria. In this update, we identified three ongoing randomised controlled trials. Among the eight excluded studies were three randomised trials comparing HBOT with no treatment that included patients with fractures. One of these trials had been abandoned and the other two did not report on fracture healing outcomes. AUTHORS' CONCLUSIONS: This systematic review failed to locate any relevant clinical evidence to support or refute the effectiveness of HBOT for the management of delayed union or established non-union of bony fractures. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of these injuries. There are three randomised controlled trials underway and we anticipate these will help provide some relevant clinical evidence to address this issue in the future.

Backout of the helical blade of proximal femoral nail antirotation and accompanying fracture nonunion.

This article describes a case of backout of the helical blade, a rare complication of proximal femoral nail antirotation. A 31-year-old man had sustained a trochanteric fracture of his right femur. Fracture fixation using proximal femoral nail antirotation and autologous bone grafting 7 months later were performed at another hospital. However, bony union was not obtained, and the patient's pain and limp persisted. Therefore, he presented to the current authors. A radiograph taken at presentation revealed backout of the helical blade and fracture nonunion. A radiograph taken 1 month later showed a more advanced backout of the helical blade. The authors performed exchange nailing supplemented with transplantation of peripheral blood CD34-positive cells and autologous bone grafting. The proximal femoral nail antirotation was revised to a long gamma 3 nail, and a U-lag screw was used to obtain better stability. The postoperative course was uneventful. The patient regained ambulation without pain or support at 12 weeks postoperatively. Radiographic bony union was completed 9 months postoperatively. At 1-year follow-up, he could run and stand on the previously injured leg and had returned to work. Backout of the helical blade should be considered as a possible complication of proximal femoral nail antirotation. Incomplete fixation of the helical blade is the possible reason for backout. The use of a helical blade in young patients may cause difficulty in insertion and result in incomplete fixation.

Pulsed electromagnetic fields for the treatment of tibial delayed unions and nonunions. A prospective clinical study and review of the literature.

BACKGROUND: Pulsed electromagnetic fields (PEMF) stimulation for the treatment of bone nonunion or delayed union have been in use for several years, but on a limited basis. The aim of this study was to assess the overall efficacy of the method in tibial delayed unions and nonunions and identify factors that could affect the final outcome. METHODS: We prospectively reviewed 44 patients (27 men) with a mean age of 49.6 ± 18.4 years that received PEMF therapy due to tibial shaft delayed union or nonunion. In all cases, fracture gap was less than 1 cm and infection or soft tissue defects were absent. RESULTS: Fracture union was confirmed in 34 cases (77.3%). No relationship was found between union rate and age (p = 0.819), fracture side (left or right) (p = 0.734), fracture type (simple or comminuted, open or closed) (p = 0.111), smoking (p = 0.245), diabetes (p = 0.68) and initial treatment method applied (plates, nail, plaster of paris) (p = 0.395). The time of treatment onset didn't affect the incidence of fracture healing (p = 0.841). Although statistical significance was not demonstrated, longer treatment duration showed a trend of increased probability of union (p = 0.081). CONCLUSION: PEMF stimulation is an effective non-invasive method for addressing non-infected tibial union abnormalities. Its success is not associated with specific fracture or patient related variables and it couldn't be clearly considered a time-dependent phenomenon.

WITHDRAWN: Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than one atmosphere absolute (ATA) in a pressure vessel. This technology has been used to treat a variety of diseases and has been described as helping patients who have delayed healing or established non-union of bony fractures. OBJECTIVES: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of delayed bony healing and established non-union of bony fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2008), the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2008), MEDLINE (OVID 1966 to April week 3, 2008), CINAHL (OVID 1982 to April week 3, 2008), EMBASE (OVID 1980 to week 17 2008), the locally developed Database of Randomised Controlled Trials in Hyperbaric Medicine (available at www.hboevidence.com) from inception to May 2008, and reference lists of articles. SELECTION CRITERIA: We aimed to include all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: We planned independent data collection by two authors using standardised forms. MAIN RESULTS: No trials met the inclusion criteria. We excluded one trial that compared HBOT with no treatment because no clinical outcomes were reported. AUTHORS' CONCLUSIONS: This systematic review failed to locate any relevant clinical evidence to support or refute the effectiveness of HBOT for the management of delayed union or established non-union of bony fractures. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of these injuries.

Recognition, assessment, and treatment of non-union after surgical fixation of fractures: emphasis on 3D CT.

For the post-operative patient, conventional axial computed tomography (CT) imaging and 2D multiplanar reconstruction are of limited value because of the beam-hardening artifact. However, three-dimensional (3D) CT imaging is an effective means of detecting subtle fracture healing, or confirming non-union, and for evaluating the integrity of metal hardware. In this article we emphasize the advantages of 3D CT imaging in the assessment and preoperative planning of non-union for patients who have been surgically treated for fractures.

Pulsed electromagnetic field stimulation for acute tibial shaft fractures: a multicenter, double-blind, randomized trial.

BACKGROUND: Tibial shaft fractures are sometimes complicated by delayed union and nonunion, necessitating further surgical interventions. Pulsed electromagnetic field stimulation is an effective treatment for delayed unions and nonunions, but its efficacy in preventing healing complications in patients with acute fractures is largely untested. The purpose of this pragmatic trial was to determine whether adjuvant pulsed electromagnetic field therapy for acute tibial shaft fractures reduces the rate of surgical revision because of delayed union or nonunion. METHODS: In a double-blind randomized trial involving six metropolitan trauma hospitals, 259 participants with acute tibial shaft fractures (AO/OTA type 42) were randomized by means of external allocation to externally identical active and inactive pulsed electromagnetic field devices. Participants were instructed to wear the device for ten hours daily for twelve weeks. Management was otherwise unaltered. The primary outcome was the proportion of participants requiring a secondary surgical intervention because of delayed union or nonunion within twelve months after the injury. Secondary outcomes included surgical intervention for any reason, radiographic union at six months, and the Short Form-36 Physical Component Summary and Lower Extremity Functional Scales at twelve months. Main analyses were by intention to treat. RESULTS: Two hundred and eighteen participants (84%) completed the twelve-month follow-up. One hundred and six patients were allocated to the active device group, and 112 were allocated to the placebo group. Compliance was moderate, with 6.2 hours of average daily use. Overall, sixteen patients in the active group and fifteen in the inactive group experienced a primary outcome event (risk ratio, 1.02; 95% confidence interval, 0.95 to 1.14; p = 0.72). According to per-protocol analysis, there were six primary events (12.2%) in the active, compliant group and twenty-six primary events (15.1%) in the combined placebo and active, noncompliant group (risk ratio, 0.97; 95% confidence interval, 0.86 to 1.10; p = 0.61). No between-group differences were found with regard to surgical intervention for any reason, radiographic union, or functional measures. CONCLUSIONS: Adjuvant pulsed electromagnetic field stimulation does not prevent secondary surgical interventions for delayed union or nonunion and does not improve radiographic union or patient-reported functional outcomes in patients with acute tibial shaft fractures.

Management of aseptic tibial nonunion.

Tibial nonunion remains a significant clinical challenge despite advances in surgical management. New techniques to help manage tibial nonunion include extracorporeal shock wave therapy and percutaneous application of bone marrow aspirate. Management strategies vary based on the type of nonunion: aseptic or infected, and atrophic or hypertrophic. Extracorporeal shock wave therapy has been shown to be as effective as surgical management in patients with stable hypertrophic nonunion. New fixation options include locked plates and intramedullary compression nails. Novel methods of external fixation have been developed for bone graft harvest from the intramedullary canal. Several biologic adjuncts also are available, including bone marrow aspirates, stem cells, and bone morphogenetic protein.

Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults.

BACKGROUND: Delayed union and non-union of fractures are a considerable cause of morbidity to patients. Laboratory studies have shown that electromagnetic fields can stimulate the formation of new bone, indicating a potential role for electromagnetic stimulation in the treatment of fractures that have failed to heal. OBJECTIVES: To assess the effects of electromagnetic stimulation for treating delayed union or non-union of long bone fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (May 2010), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2010, Issue 2), MEDLINE (1966 to May 2010) and EMBASE (1980 to 2010 Week 20), trial registers and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials evaluating electromagnetic field stimulation for the treatment of delayed union or non-union of long bones in adults. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies and performed data extraction and risk of bias assessment. Treatment effects were assessed using risk ratios and, where appropriate, data were pooled using a random-effects model. MAIN RESULTS: Four studies, involving 125 participants, were included. Three studies evaluated the effects of pulsed electromagnetic fields and one study, capacitive coupled electric fields. Participants with delayed union and non-union of the long bones were included, but most data related to non-union of the tibia. Although all studies were blinded randomised placebo-controlled trials, each study had limitations.The primary measure of the clinical effectiveness of electromagnetic field stimulation was the proportion of participants whose fractures had united at a fixed time point. The overall pooled effect size was small and not statistically significant (risk ratio 1.96; 95% confidence interval 0.86 to 4.48; 4 trials). There was substantial clinical and statistical heterogeneity in this pooled analysis (I(2) = 58%). A sensitivity analysis conducted to determine the effect of multiple follow-up time-points on the heterogeneity amongst the studies showed that the effect size remained non-significant at 24 weeks (risk ratio 1.61; 95% confidence interval 0.74 to 3.54; 3 trials), with similar heterogeneity (I(2) = 57%).There was no reduction in pain found in two trials. No study reported functional outcome measures. One trial reported two minor complications resulting from treatment. AUTHORS' CONCLUSIONS: Though the available evidence suggests that electromagnetic field stimulation may offer some benefit in the treatment of delayed union and non-union of long bone fractures, it is inconclusive and insufficient to inform current practice. More definitive conclusions on treatment effect await further well-conducted randomised controlled trials.