Rate of Tibiotalocalcaneal (TTC) Fusion Using the Surgical Implant Generation Network (SIGN) Intramedullary Nail in Developing Countries.

Outcomes of the Surgical Implant Generation Network (SIGN) nail have been reported for femur and tibial fractures, but its use in tibiotalocalcaneal arthrodesis (TTCA) is not well studied. Radiographic and clinical outcomes of TTCA using the SIGN database in patients with > 6 months of radiographic follow up were analyzed. Rates of tibiotalar (TT) fusion and subtalar (ST) fusion at final follow up were assessed by two independent reviewers. Of the 62 patients identified, use of the SIGN nail for TCCA resulted in 53% rate of fusion in the TT joint and 20% in the ST joint. Thirty-seven patients (60%) demonstrated painless weight bearing at final follow up. There were no differences in incidence of painless weight bearing between consensus fused and not fused cohorts for TT and ST joints (p > 0.05). There were five implant failures, no cases of infection, and seven cases of reoperation. (Journal of Surgical Orthopaedic Advances 32(3):187-192, 2023).

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.

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.

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.

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.

Delays in Debridement of Open Femoral and Tibial Fractures Increase Risk of Infection.

BACKGROUND: Infection remains a costly, devastating complication following the treatment of open fractures. The appropriate timing of debridement is controversial, and available evidence has been conflicting. METHODS: This study is a retrospective analysis of the SIGN (Surgical Implant Generation Network) Surgical Database (SSDB), a prospective registry of fracture cases in predominantly low-resource settings. Skeletally mature patients (≥16 years of age) who returned for follow-up at any time point after intramedullary nailing of an open femoral or tibial fracture were included. Patients were excluded if they had delays in debridement exceeding 7 days after the injury. Utilizing a model adjusting for potential confounders, including patient demographic characteristics, injury characteristics, country income level, and hospital type and resources, local logistic regression analysis was performed to evaluate the probability of infection with increasing time to debridement in 6-hour increments. RESULTS: In this study, 27.3% of patients met the eligibility criteria and returned for follow-up, with a total of 10,651 fractures from 61 countries included. Overall, the probability of infection increased by 0.17% for every 6-hour delay in debridement. On subgroup analysis, the probability of infection increased by 0.23% every 6 hours for Gustilo-Anderson type-III injuries compared with 0.13% for Gustilo-Anderson type-I or II injuries. The infection risk increased every 6 hours by 0.18% for tibial fractures compared with 0.13% for femoral fractures. CONCLUSIONS: There was a linear and cumulative increased risk of infection with delays in debridement for open femoral and tibial fractures. Such injuries should be debrided promptly and expeditiously. The size and international nature of this cohort make these findings uniquely generalizable to nearly all environments where such injuries are treated. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Predictors of nonunion for transverse femoral shaft fractures treated with intramedullary nailing: a SIGN database study.

Introduction: Nonunion is a common postfracture complication resulting in decreased quality of life for patients in resource-limited settings. This study aims to determine how age, sex, injury mechanism, and surgical intervention affect the rate of nonunion in transverse femur fractures treated with a SIGN intramedullary nail (IMN). Methods: A retrospective study was conducted using the SIGN online surgical database. All patients older than 16 years with simple transverse (<30 degrees), open or closed, femur fractures treated using a SIGN IMN between 2007 and 2021 were included. Our primary outcome of nonunion was measured with the modified Radiographic Union Scale for Tibial fractures (mRUST); scores ≤9 of 16 defined nonunion. The secondary outcome was squat depth. Outcomes were evaluated at follow-up appointments between 240 and 365 days postoperatively. Univariate and multivariate analysis were used for statistical comparison. Results: Inclusion criteria were met for 182 patients. The overall radiographic union rate was 61.0%, and a high proportion (84.4%) of patients could squat with their hips at or below the level of their knees. Older age, retrograde approach, and fracture distraction were associated with nonunion, but sex, injury mechanism, and other surgical variables were not. Conclusion: Poor reduction with fracture distraction was associated with a higher rate of nonunion. Loss of follow-up may have contributed to our overall union rate; however, we observed high rates of functional healing using the SIGN IMN. Level of evidence: IV.

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.

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.

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.

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.

[Nailing of long bone fractures in precarious situations: focus on the Surgical Implant Generation Network (SIGN) nail]. / Enclouage des os longs en situation précaire: intérêt du clou SIGN (Surgical Implant Generation Network).

Economic development in low-income countries has led to a considerable increase in motor vehicles, in particular motorcycles. Traffic accident-related fractures are therefore increasing. The treatment of long bone fractures is, in the majority of cases, based on locked intramedullary nailing, a procedure which is rarely available in countries with poor sanitary conditions. To provide optimal treatment to these countries, the SIGN (Surgical Implant Generation Network) nail was developed in 1999 by Lewis Zirkle. It is currently used free of charge in 53 countries. In return, an international database must be completed in order to assess and develop it. In the light of our experiences in Haiti and Burundi and on the basis of a literature review, we here highlight the conceptual and technical features of SIGN nail whose implant in French-speaking countries is still limited.

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.

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.

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.

Clinical Outcomes and Complications of the Surgical Implant Generation Network (SIGN) Intramedullary Nail: A Systematic Review and Meta-Analysis.

OBJECTIVES: This study is a systematic review and meta-analysis of the clinical outcomes and pooled complication rate of femoral, tibial, and humeral fracture fixation using SIGN nails. We aimed at comparing the pooled rate of adverse events based on the country of study origin, acute versus delayed fracture fixation, and length of follow-up. METHODS: We searched PubMed/MEDLINE/Cochrane databases from 2000 to 2016 for English language studies. There was substantial heterogeneity among included studies. Therefore, we used subgroup analysis of varying adverse events and removal of potential outlier studies based on the "remove one" sensitivity analysis to address the heterogeneity across studies. A funnel plot was drawn and inspected visually to assess publication bias. We reported pooled complication rates for each adverse event with 95% prediction interval. RESULTS: There were 14 studies with 47,169 cases across 58 different low- and middle-income countries. The average age was 33 ± 14 years, with 83% men and 17% women. Sixty percent of SIGN nails used in these 14 studies were used in femur fracture fixation, 38% in tibial shaft fractures, and the remaining 2% for humeral shaft fractures. Approximately 23% of patients had follow-up data recorded. All studies that measured clinical outcome indicated that >90% achieved full weight-bearing status, favorable range of motion (knee range of motion >90 degrees according to the SIGN database), and radiographic or clinical union depending on the specific variable(s) measured in each study. The overall complication rate was 5.2% (4.4%-6.4%). Malalignment (>5 degrees of angulation in any plane) was the most common complication (7.6%), followed by delayed/nonunion (6.9%), infection (5.9%), and hardware failure, (3.2%). CONCLUSIONS: Overall, the use of SIGN nails in fixing femoral, tibial, and humeral shaft fractures demonstrates good results with a high rate of return to full weight-bearing and radiographic/clinical union. The most common complications when using the SIGN nail are malalignment, delayed/nonunion, infection, and hardware failure. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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.

Development of Squat-and-Smile Test as Proxy for Femoral Shaft Fracture-Healing in Patients in Dar es Salaam, Tanzania.

BACKGROUND: There are few validated instruments that serve as a proxy for fracture-healing after lower-extremity trauma in low-resource settings. The squat-and-smile test (S&S) has been under development by SIGN (Surgical Implant Generation Network) Fracture Care International to monitor outcomes of lower-extremity long-bone fractures after intramedullary nailing in resource-limited settings. The goals of this study were to develop and identify domains of the S&S test. METHODS: The S&S domains were developed through an iterative process, and consensus was achieved regarding 3: squat depth, support needed to squat, and facial expression. Adult patients with an OTA/AO type-32 femoral shaft fracture were included in this retrospective study and had the S&S administered at 6 weeks and 3, 6, and 12 months postoperatively. Two authors independently assessed photographs of the patients performing the S&S. S&S domains were correlated with the EuroQol 5-Dimensions (EQ-5D) index score, and comparisons were made between S&S domains and reoperation status. Interrater and test-retest reliability was assessed using the kappa statistic. Sensitivity and specificity analyses were performed. RESULTS: Six hundred and nine S&S images were evaluated for 231 patients. Each domain improved over time and correlated positively with EQ-5D scores (p < 0.05). Squat depth and support needed to squat correlated with the need for a reoperation (p ≤ 0.01), and both had high specificity (0.95 and 0.97, respectively) for ruling out the need for a reoperation at 1 year. All 3 domains had high test-retest reliability (κ = 0.95, 0.92, and 0.96). Squat depth and need for support also had strong interrater reliability (κ = 0.75 and 0.78). CONCLUSIONS: The S&S is a potential tool for monitoring clinical and functional outcome of femoral shaft fractures in low-resource settings. Our data support the binary assessment of squat depth and need for support, but not facial expression, as a proxy for fracture-healing. Future prospective studies in external populations are warranted to evaluate the validity, reliability, and responsiveness of the S&S. CLINICAL RELEVANCE: The S&S provides a valuable proxy for femoral shaft fracture assessment for middle to low-income countries because it is locally relevant (based on squatting), it is easy to administer, and assessment can be performed remotely via mobile telephone or text messaging.

Injuries in developing countries--how can we help? The role of orthopaedic surgeons.

Each year nearly 5 million people worldwide die from injuries, approximately the number of deaths caused by HIV/AIDS, malaria, and tuberculosis combined. Ninety percent of these injuries occur in developing countries and that number is growing. Road traffic accidents account for 1.2 million of these 5 million deaths. For each death from trauma, three to eight more are permanently disabled. Orthopaedic surgeons should consider the victims of this epidemic by using their ability and capacity to treat these injuries. SIGN (Surgical Implant Generation Network, Richland, WA, USA) builds local surgical capability in developing countries by providing training and equipment to surgeons for use in treating the poor. It assists in treating long-bone fractures by using an intramedullary nail interlocking screw system. C-arm imaging, unavailable in many of these hospitals, is not necessary to accomplish interlocking. Surgery is performed primarily by local surgeons who record their cases on the SIGN surgical database. Discussion of these reports provides a means of communication and education among surgeons. This database demonstrates the capability of these surgeons. It also demonstrates that the SIGN intramedullary nail is safe for use in the developing world as it has been successful in treating 36,000 trauma patients.

Early clinical cxperience with the SIGN hip construct: a retrospective case series.

BACKGROUND: As the population ages, the developing world industrializes, and more urban centers emerge, the burden of orthopedic trauma will steadily increase. SIGN Fracture Care International has developed a unique intramedullary device for fixation of hip fractures in low-resource settings lacking fluoroscopy. The purpose of this study is to report the safety profile and complication rate for a consecutive series of hip fracture patients managed using this implant. METHODS: We conducted a retrospective analysis of the first 170 patients treated with the SIGN Hip Construct (SHC) from 2009 to 2014 using the SIGN Online Surgical Database (SOSD). Patients with follow-up greater than 12 weeks and adequate radiographs were included. Data recorded include patient demographics, time-to-surgery, union rate, AO/OTA classification, complications, neck-shaft angle, and clinical outcomes including painless weight bearing and knee flexion greater than 90°. RESULTS: Of 170 patients, 71 met inclusion criteria with mean follow-up of 39 weeks. Mean age was 49.5 and by WHO, regions were Africa (27), Eastern Mediterranean (21), Western Pacific (17), Americas (3), and Southeast Asia (3). Fractures included intertrochanteric (55), subtrochanteric (7), femoral neck (4), and combined (5). Reduction quality was good in 35 (49%), acceptable in 19 (27%), and poor in 17 (24%). Major complications consisted of varus collapse (6), non- or delayed union (3), intra-articular screw (5), and infection (3). Average postoperative neck-shaft angle was 126° and 119.3° at final follow-up. CONCLUSIONS: This is the first comprehensive report of a novel implant for hip fractures specifically designed for low-resource settings. The early clinical data and outcomes suggest that the SHC can be safely inserted in the absence of fluoroscopy, and facilitates early mobilization while maintaining acceptable reduction until union.