Intramedullary Fixation for Pediatric Femoral Nonunion in Low- and Middle-Income Countries.

BACKGROUND: Pediatric femoral shaft nonunion after use of a plate or intramedullary nail (IMN) is uncommon in the United States. In low and middle-income countries, as defined by The World Bank, these complications may occur with greater frequency. We assessed the rates of union and painless weight-bearing after IMN fixation of pediatric femoral shaft nonunion in lower-resource settings. METHODS: We queried the SIGN (Surgical Implant Generation Network) Fracture Care International online database to identify all pediatric femoral shaft nonunions that had occurred since 2003 and had ≥3 months of follow-up after their treatment; our query identified 85 fractures in 83 patients. We defined nonunion as failure of initial instrumentation >90 days following its placement, lack of radiographic progression on radiographs made >3 months apart, or the absence of signs of radiographic healing >6 months after initial instrumentation. We evaluated the most recent follow-up radiograph to determine a Radiographic Union Scale in Tibial fractures (RUST) score. We also recorded rates of painless full weight-bearing as assessed by the treating surgeon. RESULTS: Fifty-seven patients with pediatric femoral shaft nonunions (including 42 male and 15 female patients from 18 countries) were included. The average age (and standard deviation) at the time of revision surgery was 13.8 ± 3.0 years (range, 6 to 17 years). The median duration of follow-up was 67 weeks (range, 13 weeks to 7.7 years). The initial instrumentation that went on to implant failure included plate constructs (56%), non-SIGN IMNs (40%), and SIGN IMNs (4%). At the time of the latest follow-up, 52 patients (91%) had a RUST score of ≥10 and 51 (89%) had painless full weight-bearing. No patient had radiographic evidence of femoral head osteonecrosis at the time of complete fracture-healing or the latest follow-up. CONCLUSIONS: Pediatric femoral shaft nonunion can occur after both plate and IMN fixation in low and middle-income countries. IMN fixation is an effective and safe treatment for these injuries. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.

Outcome of tibial shaft fractures treated with the SIGN FIN nail at Addis Ababa Emergency, Burn, and Trauma Hospital (AaEBT) Addis Ababa, Ethiopia.

Objectives: To determine the outcome of tibial fractures treated with the SIGN FIN nail. Study Design: Retrospective case series study. Study Setting: Trauma center. Methods and Materials: We included 14 patients aged 18-51 years with 16 tibial fractures in this study. Patients were followed clinically and radiographically, and the minimum time followed was 6 months. Johner and Wruhs criteria with modification were used to assess the outcome. Result: There were 11 male (78.6%) and three female (21.4%) patients. The mean age was 32.44 ± 8.98 (range 18-51) years. The right-sided tibia was injured in six as compared with the left side in four, and four patients had bilateral injuries. Eight (50%) fractures were closed fractures, whereas the rest eight (50%) were open types of fractures. Among the latter, half (n = 4; 50%) fractures were Gustilo type II fractures, while three (37.5%) fractures were Gustilo type III fractures, and one (12.5%) patient had a Gustilo type I fracture. All patients had radiologic union. There were no infections or secondary surgery for any reason. Excellent, good, and fair results were achieved in 62.5%, 25%, and 12.5%, respectively. All patients were able to return to their preinjury activity except two patients. Conclusion: SIGN FIN nail is an option for treating tibial shaft fractures with good outcomes and few complications in selected fractures. Level of evidence: Level IV.

The Influence of Retrograde Femoral Nail Removal With and Without Interpositional Fat Grafting on Distal Femoral Physeal Behavior: A Sheep Study.

BACKGROUND: Previous investigations have demonstrated that up to 7% of the distal femoral physis can be violated using a rigid, retrograde nail without growth inhibition or arrest. The purpose of this investigation was to evaluate the behavior of the distal femoral physis after retrograde femoral nail removal in a sheep model, with and without placement of an interpositional fat graft. METHODS: Retrograde femoral nails were placed in 8 skeletally immature sheep. Implants were removed at 8 weeks, with the residual defects left open (n=4) or filled with autologous fat graft (n=4). Differences in femoral length between surgical versus contralateral control femurs were measured after an additional 3 (n=4) or 5 months (n=4) before sacrifice, and the physis was evaluated histologically. RESULTS: When compared with control limbs, femoral length was significantly shorter in limbs sacrificed at 3 months (mean: 3.9±1.3 mm; range: 2.7 to 5.7 mm) compared with limbs at 5 months (mean: 1.0±0.4 mm; range: 0.4 to 1.2 mm) ( P =0.005). No significant difference in mean shortening was appreciated in limbs without (2.4±1.6 mm) versus with fat grafting (2.5±2.3 mm) ( P =0.94). Histologic analysis revealed no osteoid formation across the physis in sheep sacrificed at 3 months, whereas there was evidence of early osteoid formation across the physis in sheep at 5 months. All specimens demonstrated evidence of an active physes. CONCLUSIONS: Femurs undergoing retrograde implant placement were significantly shorter when compared with control limbs in sheep sacrificed at 3 months, whereas differences were nominal in sheep sacrificed at 5 months after retrograde implant removal, suggesting growth inhibition with nail removal improved with time. Fat grafting across the distal femoral physis did not result in a significant difference in femoral lengths. Histologic evidence at 5 months revealed early development of a bone bridge, emphasizing the importance of follow-up to skeletal maturity in patients treated with retrograde nailing across an open physis. LEVEL OF EVIDENCE: Level IV.

Fixation of intertrochanteric femur fractures using the SIGN intramedullary nail augmented by a lateral plate in a resource-limited setting without intraoperative fluoroscopy: assessment of functional outcomes at one-year follow-up at Juba Teaching Hospital.

OBJECTIVES: The incidence of hip fracture is high and increasing globally due to an aging population. Morbidity and mortality from these injuries are high at baseline and worse without prompt surgical treatment to facilitate early mobilization. Due to resource constraints, surgeons in low-income countries often must adapt available materials to meet these surgical needs. The objective of this study is to assess functional outcomes after surgical fixation of intertrochanteric femur fractures with the Surgical Implant Generation Network (SIGN) intramedullary nail augmented by a lateral SIGN plate. DESIGN: Prospective case series. SETTING: Juba Teaching Hospital, Tertiary Referral Hospital for South Sudan. PARTICIPANTS: Adult patients with intertrochanteric hip fractures. INTERVENTION: SIGN nail augmented by a lateral plate. MAIN OUTCOME MEASUREMENTS: Primary outcome was hip function as measured by a modified Harris Hip Score (mHHS) at 1-year after surgery. Secondary endpoints were the occurrence of reoperation or infection at 1-year after surgery. RESULTS: Thirty patients were included, 16 (53%) men and 14 (47%) women, with a mean age of 62 years. Fractures were classified as AO/OTA Type 31A1 in 12 (40%) patients, 31A2 in 15 (50%) patients, and 31A3 in 3 (10%) patients. Mean mHHS at 1-year was 75.10 ±â€Š21.2 with 76% categorized as excellent or good scores. There was 1 (3%) infection and 2 (7%) reoperations. CONCLUSIONS: The SIGN nail augmented by a lateral plate achieved good or excellent hip function in the majority of patients with intertrochanteric hip fractures. This may be a suitable alternative to conventional implants for hip fracture patients in low-resource settings to allow mobilization.

Retrograde Intramedullary Nailing of Pediatric Femoral Shaft Fractures Does Not Result in Growth Arrest at the Distal Femoral Physis-A Retrospective Cases Series.

OBJECTIVE: To evaluate femoral growth after placement of retrograde intramedullary nails in the treatment of pediatric femoral shaft fractures. DESIGN: Retrospective case series. SETTING: Large urban trauma center in Mongolia. PATIENTS/PARTICIPANTS: Twenty-nine pediatric patients who sustained a diaphyseal femoral shaft fracture were included in the study. INTERVENTION: Retrograde intramedullary nail fixation with the standard, fin, or pediatric fin Surgical Implant Generation Network nail across an open distal femoral physis. MAIN OUTCOME MEASURES: The main outcome measure was the distance traveled by the intramedullary nail with respect to the distal femoral condyles and distal femoral physis from initial surgery to follow-up. RESULTS: The mean age of patients was 10.7 years (range: 7-14 years). Follow-up occurred at a mean of 292 days (range: 53-714 days). Both condyle distance and physis distance were significantly positively correlated with follow-up days, with Pearson R values of 0.90 (P < 0.001) and 0.84 (P < 0.001), respectively. Multiple regression analysis revealed that follow-up days was the only significant predictor of physis distance, whereas age, sex, percent growth plate violation, and nail fully traversing physis were not significant predictors. The nail completely crossed the physis in 5 patients and no growth arrests were found. CONCLUSIONS: This is the first study, to our knowledge, to evaluate treating femoral shaft fractures with a retrograde nail across an open distal femoral physis. In the pediatric population, the use of a retrograde femoral intramedullary nails does not seem to cause growth arrest of the injured femur during the postoperative period and may be a reasonable treatment option when other surgical options are not available. Additional study is necessary to further evaluate the safety profile. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Clinical and radiographic outcomes following retrograde SIGN fin nailing for femoral shaft fractures.

PURPOSE: The Surgical Implant Generation Network (SIGN) intramedullary nail was designed for use in resource limited settings which often lack fluoroscopy, specialized fracture tables, and power reaming. A newer design iteration, the SIGN Fin nail, was developed to further simplify retrograde femoral nailing by making proximal interlocking screw placement unnecessary. Instead, the leading end of the Fin nail achieves stability through an interference fit within the proximal femoral canal. While the performance of the traditional SIGN nail has been reported previously, no large series has examined long-term clinical and radiographic outcomes of femoral shaft fractures treated with the SIGN Fin nail. METHODS: The SIGN online surgical database was used to identify all adult femoral shaft fractures treated with the SIGN Fin nail since its introduction. All patients with minimum 6 month clinical and radiographic follow-up were included in the analysis. Available demographic, injury, and surgical characteristics were recorded. Fracture alignment was evaluated on final follow-up radiographs using a previously validated on-screen protractor tool. Coronal and sagittal plane alignment measurements were recorded as deviation from anatomic alignment (DFAA), with units in degrees. Fracture healing was assessed on final follow-up radiographs, with union defined as any bridging callus and/or cortical remodeling across one cortex on orthogonal views. Clinical outcomes available in the database included knee range of motion (ROM) greater than 90° and weight-bearing status at final follow-up. Clinical and radiographic outcomes were then compared between patients with united and nonunited fractures. RESULTS: The database query identified 249 femoral shaft fractures stabilized with the Fin nail in 242 patients who had minimum 6 month clinical and radiographic follow-up. Final follow-up radiographs were performed at an average of 48 weeks postoperatively. Average coronal and sagittal plane alignment measured on final follow-up radiographs were 2.18° and 2.58°, respectively. The rate of malalignment (DFAA > 10° in either plane) at final follow-up was 6%. Two hundred twenty-nine fractures (92%) were united at final follow-up. Overall, 209 (84%) of patients achieved full weight bearing and 214 (86%) achieved knee ROM >90° at final follow-up. Compared to patients with united fractures, those with nonunion were less likely to achieve full weight bearing (20% vs 90%, P < .001) and knee ROM >90° (30% vs 91%, P < .001). There was no significant difference in mean DFAA between united and nonunited fractures in the coronal (2.1° vs 3.8°, P = .298) or sagittal (2.5° vs 3.5°, P = .528) planes. CONCLUSION: The SIGN Fin nail achieves satisfactory radiographic alignment and clinical outcomes at minimum 6 month follow-up. The overall union rate is comparable to that achieved with the standard SIGN nail. Ease of implantation makes the Fin nail an attractive option in resource-limited settings.

Risk Factors for Infection After Intramedullary Nailing of Open Tibial Shaft Fractures in Low- and Middle-Income Countries.

OBJECTIVES: (1) To determine the infection rate after fixation of open tibial shaft fractures using the Surgical Implant Generation Network (SIGN) intramedullary nail in low- and middle-income countries (LMICs) and (2) to identify risk factors for infection. DESIGN: Prospective cohort study using an international online database. SETTING: Multiple hospitals in LMICs worldwide. PATIENTS/PARTICIPANTS: A total of 1061 open tibia fractures treated with the SIGN nail in LMICs between March 2000 and February 2013. INTERVENTION: Intravenous antibiotic administration, surgical debridement, and definitive intramedullary nailing within 14 days of injury. MAIN OUTCOME MEASUREMENTS: Deep or superficial infection at follow-up, implant breakage/loosening, angular deformity >10 degrees, repeat surgery, radiographic union, weight bearing, and ability to kneel. RESULTS: The overall infection rate was 11.9%. Infection rates by the Gustilo and Anderson classification were type 1: 5.1%, type II: 12.6%, type IIIa: 12.5%, type IIIb: 29.1%, and type IIIc: 16.7% (P = 0.001 between groups). Patients who developed infection had a longer mean time from injury to definitive surgery (4.7 vs. 3.9 days, P = 0.03) and from injury to wound closure (13.7 vs. 3.6 days, P < 0.001). Distal fractures had a higher infection rate than midshaft fractures (13.3% vs. 8.2%, P = 0.03). Infection rates were not associated with time from injury to initial debridement, time from injury to initial antibiotic administration, or total duration of antibiotics. CONCLUSIONS: Open tibia fractures can be managed effectively using the SIGN intramedullary nail in LMICs with an overall infection rate of 11.9%. Risk factors for infection identified include more severe soft-tissue injury, delayed nailing, delayed wound closure, and distal fracture location. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Consequences Following Distal Femoral Growth Plate Violation in an Ovine Model With an Intramedullary Implant: A Pilot Study.

BACKGROUND: Retrograde femoral nailing in skeletal immature patients would broaden the surgical options for fracture care and reconstructive procedures but involves violation of the open, active distal femoral physis with the potential for growth disturbance. The tolerance for putting a large diameter metal implant across the physis is largely unknown. The purpose of this pilot investigation was to define the upper limit of cross-sectional violation with a metal implant before causing premature growth arrest or inhibition using a sheep model. METHODS: Eighteen sheep underwent placement of a retrograde, intramedullary implant at 3-months of age through an open distal femoral physis. The cross-sectional area of the physis was measured preoperatively and implants were selected that violated 3% to 8% of the cross-sectional area of the physis. Growth across the distal femoral physis was examined radiographically following surgery. Following euthanasia, both operative and no operative femurs were removed to compare differences in maximal lengths. RESULTS: The distal femora grew an average of 10.6±2.2 mm radio graphically after implantation. When compared with control specimens, only operative specimens with 8% of physeal violation demonstrated significant growth discrepancy with operative femurs measuring <2.1 mm in length compared with the contralateral control femur. Histologic analysis did not demonstrate any significant physeal bars formation. CONCLUSION: Distal femoral growth continues across the physis when 3% to 7% of the cross-sectional area of the physis is violated using a retrograde intramedullary implant. Specimens with 8% of growth violation demonstrated significant growth inhibition. As such, retrograde nailing through the distal femoral physis appears safe up to 7%. On the basis of previous anatomic data in humans and average nail sizes, violations of >6% of the physis with pediatric retrograde nailing would be uncommon. These findings suggest that retrograde nailing may be a viable option and merits further study. LEVEL OF EVIDENCE: Level IV-case series.

Evaluation of Intramedullary Fixation for Pediatric Femoral Shaft Fractures in Developing Countries.

OBJECTIVES: To report the clinical results after treatment of pediatric femoral shaft fractures with the SIGN Fracture Care International (SIGN) pediatric and standard fin nails. DESIGN: Retrospective review of prospectively collected data. SETTING: Sixteen global SIGN centers from 2003 to 2013. PATIENTS/PARTICIPANTS: One hundred twelve pediatric patients who sustained a diaphyseal pediatric femoral shaft fracture. INTERVENTION: Intramedullary fixation with the standard or pediatric SIGN nail. MAIN OUTCOME MEASUREMENTS: Main outcome measurements include clinical and radiographic healing and postoperative complications. RESULTS: The mean age of the pediatric fin patients was 9.4 years (4-15) and 11.2 years (4-18) for the standard fin patients. Painless weight bearing was achieved in 94.7% and 94.5% of the patients at the last follow-up. In total, 23 patients had repeat surgery for the removal of implant. Failure of implant with bending of the nail and/or a valgus or varus deformity (>10 degrees) was noted in 7/57 (12.3%) of the patients treated with the pediatric fin nail, of which 6/7 were >10 years old. Five of these 7 patients were classified as technical errors attributed to inadequate nail diameter, length, or initial malreduction. No complications were noted at any age in the standard fin nail group. CONCLUSIONS: In resource-poor settings, SIGN pediatric fin and standard fin nails seem to be an effective treatment option for femoral shaft fractures. In patients with larger canals, the surgeon should consider using the standard fin nail for improved stability and to minimize potential complications. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

State of Pelvic and Acetabular Surgery in the Developing World: A Global Survey of Orthopaedic Surgeons at Surgical Implant Generation Network (SIGN) Hospitals.

OBJECTIVES: To document the current state of pelvic and acetabular surgery in the developing world and to identify critical areas for improvement in the treatment of these complex injuries. DESIGN: A 50-question online survey. SETTING: International, multicenter. PATIENTS/PARTICIPANTS: One hundred eighty-one orthopaedic surgeons at Surgical Implant Generation Network (SIGN) hospitals, which represent a cross-section of institutions in low- and middle-income countries that treat high-energy musculoskeletal trauma. INTERVENTIONS: Administration and analysis of 50-question survey. MAIN OUTCOME MEASURES: Surgeon training and experience; hospital resources; volume and patterns of pelvic/acetabular fracture management; postoperative protocols and resources for rehabilitation; financial responsibilities for patients with pelvic/acetabular fractures. RESULTS: Complete surveys were returned by 75 institutions, representing 61.8% of the global SIGN nail volume. Although 96% of respondents were trained in orthopaedic surgery, 53.3% have no formal training in pelvic or acetabular surgery. Emergency access to the operating room is available at all responding sites, but computed tomography scanners are available at only 60% of sites, and a mere 21% of sites have access to angiography for pelvic embolization. Cannulated screws (53.3%) and pelvic reconstruction plates (56%) are available at just over half of the sites, and 68% of sites do not have pelvic reduction clamps and retractors. 21.3% of sites do not have access to intraoperative fluoroscopy. Responding hospitals see an average of 38.8 pelvic ring injuries annually, with 24% of sites treating them all nonoperatively. Sites treated an average of 22.5 acetabular fractures annually, with 34.7% of institutions treating them all nonoperatively. Patients travel up to 1000 km or 20 hours for pelvic/acetabular treatment at some sites. Although 78.7% of sites have inpatient physical or occupational therapy services, only 17% report access to home physical therapy, and only 9% report availability of nursing or rehabilitation facilities postdischarge. At over 80% of hospitals, patients and their families are at least partially responsible for payment of surgical, implant, hospital, and outpatient fees. Government aid is available for inpatient fees at over 40% of sites, but outpatient services are subsidized at only 28% of sites. CONCLUSIONS: We report the current state of pelvic and acetabular surgery in low- and middle-income countries. Our results identify significant needs in surgeon training, hospital resources, availability of instruments and implants, and access to appropriate postoperative rehabilitation services for pelvic and acetabular surgery in the developing world. Targeted programs designed to overcome these barriers are required to advance the care of pelvic and acetabular fractures in the developing world.

Understanding and Addressing the Global Need for Orthopaedic Trauma Care.

➤The burden of musculoskeletal trauma is high worldwide, disproportionately affecting the poor, who have the least access to quality orthopaedic trauma care.➤Orthopaedic trauma care is essential, and must be a priority in the horizontal development of global health systems.➤The education of surgeons, nonphysician clinicians, and ancillary staff in low and middle income countries is central to improving access to and quality of care.➤Volunteer surgical missions from rich countries can sustainably expand and strengthen orthopaedic trauma care only when they serve a local need and build local capacity.➤Innovative business models may help to pay for care of the poor. Examples include reducing costs through process improvements and cross-subsidizing from profitable high-volume activities.➤Resource-poor settings may foster innovations in devices or systems with universal applicability in orthopaedics.

Interlocked Intramedullary Nail Without Fluoroscopy.

Surgical Implant Generation Network (SIGN) was founded 15 years ago to create equality of fracture care throughout the world. This is done by education and supply of the appropriate implants and instruments to implement the education. SIGN implants have been used in 150,000 long bone fractures in developing countries. The same implants and instruments are used to provide intramedullary nail interlocking screw fixation in the tibia, femur, and humerus. The design of SIGN implants and the surgical technique are described.

Management of Distal Tibial Metaphyseal Fractures With the SIGN Intramedullary Nail in 3 Developing Countries.

OBJECTIVES: To evaluate the effectiveness of the Surgical Implant Generation Network (SIGN) intramedullary (IM) nail in distal tibial metaphyseal fractures. DESIGN: Retrospective Case Series. SETTING: Three Level I trauma centers in 3 different developing countries from 2009 to 2013. PATIENT/PARTICIPANTS: One hundred sixty patients with 162 distal tibial metaphyseal fractures (AO/OTA 43-A). INTERVENTION: SIGN IM nailing was performed using hand reaming and without the use of an image intensifier. MAIN OUTCOME MEASUREMENTS: The primary outcome measures were the rate of union and complications. The secondary outcome measures were the effect of open fractures on outcomes, effectiveness and safety of open reduction of closed fractures, and risk factors for the development of malalignment and possible solutions. RESULTS: The average age of patients was 35.3 years. Seventy-nine percent were male. Sixty percent of the fractures were closed. The mean time to surgery was 4.1 days. Fracture union occurred in 97.3% of fractures with an average time to union of 105 days. Open reduction of closed fractures was performed in 51 fractures. Nonunion occurred in 3 patients (1.8%). Acceptable alignment (<5 degrees deformity) was found in 134 fractures (83%). Infection occurred in 14 patients (8.6%). Revision surgery was required in 10 fractures (6.2%). CONCLUSIONS: In developing settings, distal metaphyseal tibial fractures can be managed successfully with the SIGN IM nail. There is an increased risk for complications (P = 0.001) and infection (P = 0.0004) in open fractures. Open reduction of closed distal tibia fractures is safe and effective. Malalignment can be improved with fibula stabilization but indications remain unclear. For surgeons interested in international mission work, the SIGN IM nail is an effective tool in managing distal tibial fractures. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The SIGN Nail: Factors in a Successful Device for Low-Resource Settings.

Surgeons in low-resource settings manage an increasing number of patients presenting with high-energy fractures. The number of surgeons and the operating time available are frequently not adequate to treat these fractures in a timely manner. A common cause of delay in treating fractures is waiting for the patient to accumulate sufficient funding to pay for the surgery, including the surgical implant. The donation of the SIGN intramedullary nail interlocking screw system obviates a major delay in timing of surgery. The SIGN intramedullary nail has been designed to be used in low-resource settings as it can be placed without fluoroscopy or electricity. The SIGN-trained surgeons are very skillful in hand reaming the canal, placing the nail, and interlocking screws without fluoroscopy. As more is learned about fracture healing, the SIGN system continues to evolve. The SIGN system is expanding to include deformity correction and soft tissue coverage.

Comparison of SIGN Pediatric and Fin nails in pediatric diaphyseal femur fractures: early clinical results.

OBJECTIVES: The purpose of this study was to evaluate the effectiveness of SIGN Pediatric and Fin nails in treating pediatric diaphyseal femur fractures. DESIGN: Prospective case series. SETTING: Level I trauma center from 2010 to 2013. PATIENT/PARTICIPANTS: Eighteen patients (13 male and 5 female) with pediatric diaphyseal femur fractures who did not achieve skeletal maturity. INTERVENTION: Femoral nailing was done using either SIGN Pediatric or Fin nail with hand-reaming without using bone-grafting or image intensifier. MAIN OUTCOME MEASUREMENTS: Patients were evaluated for infection, radiographic parameters, range of movements, time to weight-bearing (partial and complete), revision surgery (if needed), and complications. RESULTS: The average age of patients was 10.2 (±2.1) (range: 6-13) years and average time between injury and surgery was 13 (1-112) days. Fin nail was used in 13 patients, and Pediatric nail in 5 patients. There were no infections in either group. The average time for full weight-bearing was 7.07 weeks in the Fin nail group, and 8.4 weeks in the Pediatric nail group. No repeat surgeries were performed, and there was no case of avascular necrosis of femur head, limb length discrepancy, or any other complication. CONCLUSIONS: SIGN Pediatric and Fin nails are an effective treatment modality for pediatric diaphyseal femur fractures with excellent fracture healing with no major complications. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Risk factors for infection after 46,113 intramedullary nail operations in low- and middle-income countries.

BACKGROUND: The fields of surgery and trauma care have largely been neglected in the global health discussion. As a result the idea that surgery is not safe or cost effective in resource-limited settings has gone unchallenged. The SIGN Online Surgical Database (SOSD) is now one of the largest databases on trauma surgery in low- and middle-income countries (LMIC). We wished to examine infection rates and risk factors for infection after IM nail operations in LMIC using this data. METHODS: The SOSD contained 46,722 IM nail surgeries in 58 different LMIC; 46,113 IM nail operations were included for analysis. RESULTS: The overall follow-up rate was 23.1 %. The overall infection rate was 1.0 %, 0.7 % for humerus, 0.8 % for femur, and 1.5 % for tibia fractures. If only nails with registered follow-up (n = 10,684) were included in analyses, infection rates were 2.9 % for humerus, 3.2 % for femur, and 6.9 % for tibia fractures. Prophylactic antibiotics reduced the risk of infection by 29 %. Operations for non-union had a doubled risk of infection. Risk of infection was reduced with increasing income level of the country. CONCLUSIONS: The overall infection rates were low, and well within acceptable levels, suggesting that it is safe to do IM nailing in low-income countries. The fact that operations for non-union have twice the risk of infection compared to primary fracture surgery further supports the use of IM nailing as the primary treatment for femur fractures in LMIC.

Achieving locked intramedullary fixation of long bone fractures: technology for the developing world.

Eighty per cent of severe fractures occur in developing countries. Long bone fractures are treated by conservative methods if proper implants, intraoperative imaging and consistent electricity are lacking. These conservative treatments often result in lifelong disability. Locked intramedullary nailing is the standard of care for long bone fractures in the developed world. The Surgical Implant Generation Network (SIGN) has developed technology that allows all orthopaedic surgeons to treat fracture patients with locked intramedullary nailing without the need for image intensifiers, fracture tables or power reaming. Introduced in 1999, SIGN nails have been used to treat more than 100,000 patients in over 55 developing world countries. SIGN instruments and implants are donated to hospitals with the stipulation that they will be used to treat the poor at no cost. Studies have shown that patients return to function more rapidly, hospital stays are reduced, infection rates are low and clinical outcomes excellent. Cost-effectiveness analysis has confirmed that the system not only provides better outcomes, but does so at a reduced cost. SIGN continues to develop new technologies, in an effort to transform lives and bring equality in fracture care to the poorest of regions.

Antimicrobial Particulate Silver Coatings on Stainless Steel Implants for Fracture Management.

We have used particulate silver coating on stainless steel to prevent in vivo bacterial infection. Stainless steel is commonly used as an implant material for fracture management. The antimicrobial use of silver has been well documented and studied, therefore the novelty of this research is the use of a particulate coating as well as facing the real world challenges of a fracture repair implant. The variable parameters for applying the coating were time of deposition, silver solution concentration, voltage applied, heat treatment temperature between 400 to 500 °C and time. The resultant coating is shown to be non-toxic to human osteoblasts using an MTT assay for proliferation and SEM images for morphology. In vitro silver release studies of various treatments were done using simulated body fluid. The bactericidal effects were tested by challenging the coatings with P. aeruginosa in a bioreactor and compared against uncoated stainless steel. A 13-fold reduction in bacteria was observed at 24 hours and proved to be statistically significant.

Low infection rates after 34,361 intramedullary nail operations in 55 low- and middle-income countries: validation of the Surgical Implant Generation Network (SIGN) online surgical database.

BACKGROUND: The Surgical Implant Generation Network (SIGN) supplies intramedullary (IM) nails for the treatment of long bone fractures free of charge to hospitals in low- and middle-income countries (LMICs). Most operations are reported to the SIGN Online Surgical Database (SOSD). Follow-up has been reported to be low, however. We wanted to examine the pattern of follow-up and to assess whether infection rates could be trusted. PATIENTS AND METHODS: The SOSD contained 36,454 IM nail surgeries in 55 LMICs. We excluded humerus and hip fractures, and fractures without a registered surgical approach. This left 34,361 IM nails for analysis. A generalized additive regression model (gam) was used to explore the association between follow-up rates and infection rates. RESULTS: The overall follow-up rate in the SOSD was 18.1% (95% CI: 17.7-18.5) and national follow-up rates ranged from 0% to 74.2%. The overall infection rate was 0.7% (CI: 0.6-0.8) for femoral fractures and 1.2% (CI: 1.0-1.4) for tibial fractures. If only nails with a registered follow-up visit were included (n = 6,224), infection rates were 3.5% (CI: 3.0-4.1) for femoral fractures and 7.3% (CI: 6.2-8.4) for tibial fractures. We found an increase in infection rates with increasing follow-up rates up to a level of 5%. Follow-up above 5% did not result in increased infection rates. INTERPRETATION: Reported infection rates after IM nailing in the SOSD appear to be reliable and could be used for further research. The low infection rates suggest that IM nailing is a safe procedure also in low- and middle-income countries.

The role of SIGN in the development of a global orthopaedic trauma database.

BACKGROUND: The global burden of injury is receiving recognition as a major public health problem but inadequate information delays many proposed solutions. Many attempts to collect reliable data on orthopaedic trauma have been unsuccessful. The Surgical Implant Generation Network (SIGN) database is one of the largest collections of fracture cases from lower and middle income countries. QUESTIONS/PURPOSES: We describe the information in the SIGN database then address two questions: In the context of the design and implementation of a global trauma database, what lessons does the SIGN database teach? Does the SIGN program have a role in the evolution of a wider global system? METHODS: The SIGN database is Internet based. After treating a patient with a SIGN nail surgeons enter radiographs and details of the case. RESULTS: Over 26000 cases are in the SIGN database. The database has been used as a source of cases for followup studies. Analysis shows the data are of sufficient quality to allow studies of fracture patterns but not for outcome studies or bone measurement. WHERE DO WE NEED TO GO?: A global database with more comprehensive coverage of injuries, causes, treatment modalities and outcomes is needed. HOW DO WE GET THERE?: The SIGN database itself will not become a global trauma database (GTD) but the personnel of the SIGN program have much to offer in the design and adoption of a GTD. Studies of suitable methods of data collection and the incentive to use them are required.