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Background: The burden of disability because of traumatic limb amputation, particularly transfemoral amputation (TFA) is disproportionately carried by low- and middle-income countries. The need for improved access to prosthesis services in these settings is well-documented, but perspectives on the burden imposed by TFA and the challenges associated with subsequent prosthesis provision vary among patients, caregivers and healthcare providers. Objectives: To examine the burden of TFA and barriers to prosthesis provision as perceived by patient, caregiver and healthcare professional, at a single tertiary referral hospital in Tanzania. Method: Data were collected from five patients with TFA and four caregivers recruited via convenience sampling, in addition to 11 purposively sampled healthcare providers. All participants participated in in-depth interviews regarding their perceptions of amputation, prostheses and underlying barriers to improving care for persons with TFA in Tanzania. A coding schema and thematic framework were established from interviews using inductive thematic analysis. Results: All participants noted financial and psychosocial burdens of amputation, and perceived prostheses as an opportunity for return to normality and independence. Patients worried about prosthesis longevity. Healthcare providers noted significant obstacles to prosthesis provision, including infrastructural and environmental barriers, limited access to prosthetic services, mismatched patient expectations and inadequate coordination of care. Conclusion: This qualitative analysis identifies factors influencing prosthesis-related care for patients with TFA in Tanzania which are lacking in the literature. Persons with TFA and their caregivers experience numerous hardships exacerbated by limited financial, social and institutional support. Contribution: This qualitative analysis informs future directions for research into improving prosthesis-related care for patients with TFA in Tanzania. [ABSTRACT FROM AUTHOR]

Prevention of fracture-related infection (FRI) remains a substantial challenge in orthopaedic trauma care. There is evolving evidence to support the use of local antibiotics for both the prevention and treatment of musculoskeletal infection. Local antibiotics can achieve higher local tissue concentrations with a lower risk of systemic complications compared to intravenously administered antibiotics. These antibiotics may be administered in powder or liquid form without carrier, or if sustained release is desired, using a carrier. Polymethylmethacrylate (PMMA), ceramics, and hydrogels are examples of antibiotic carriers. Unlike PMMA, ceramics and hydrogels have the advantage of not requiring a second surgery for removal. The VANCO trial supported the use of powdered vancomycin in high-risk fracture cases for the reduction of Gram-positive infections; although, data is limited. Future studies will evaluate the use of aminoglycoside antibiotics to address Gram-negative infection prevention. While theoretical concerns exist with the use of local antibiotics, available studies suggest local antibiotics are safe with a low-risk of adverse effects. [ABSTRACT FROM AUTHOR]

Background: While surgeons in low and middle-income countries have increasing experience with intramedullary nailing (IMN), external fixation (EF) continues to be commonly used for the management of open tibial fractures. We examined outcomes with extended follow-up of the participants enrolled in a clinical trial comparing these treatments.Methods: Adults who were ≥18 years old with acute AO/OTA type-42 open tibial shaft fractures were randomly assigned to statically locked, hand-reamed IMN or uniplanar EF. These participants were reevaluated 3 to 5 years after treatment. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Unresolved complications such as persistent fracture-related infection, nonunion, or malalignment were collected and analyzed. Secondary outcomes included the EuroQol-5 Dimension-3 Level (EQ-5D-3L) questionnaire, the Function IndeX for Trauma (FIX-IT) score, radiographic alignment, and the modified Radiographic Union Scale for Tibial fractures (mRUST).Results: Of the originally enrolled 240 participants,126 (67 managed with IMN and 59 managed with EF) died or returned for follow-up at a mean of 4.0 years (range, 2.9 to 5.2 years). Thirty-two composite primary events occurred, with rates of 23.9% and 27.1% in the IMN and EF groups, respectively. Six of these events (3 in the IMN group and 3 in the EF group) were newly detected after the original 1-year follow-up. Unresolved complications in the form of chronic fracture-related infection or nonunion were present at long-term follow-up in 25% of the participants who sustained a primary event. The EQ-5D-3L index scores were similar between the 2 groups and only returned to preinjury levels after 1 year among patients without complications or those whose complications resolved.Conclusions: This observational study extended follow-up for a clinical trial assessing IMN versus EF for the treatment of open tibial fractures in sub-Saharan Africa. At a mean of 4 years after injury, fracture-related infection and nonunion became chronic conditions in nearly a quarter of the participants who experienced these complications, regardless of reintervention.Level Of Evidence: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Little is known about the quality of orthopaedic investigations conducted in low- and middle-income countries (LMICs). Academic collaboration is one model to build research capacity and improve research quality. Our study aimed to determine (1) the quality of clinical orthopaedic research conducted in LMICs, (2) the World Bank Regions and LMICs that publish the highest quality studies, (3) the pattern of collaboration among investigators and (4) whether academic collaboration between LMIC and non-LMIC investigators is associated with studies that have higher levels of evidence. Methods: Orthopaedic studies from 2004 to 2014 conducted in LMICs were extracted from multiple electronic databases. The World Bank Region, level of evidence and author country-affiliation were recorded. Collaboration was defined as a study that included an LMIC with non-LMIC investigator. Results: There were 958 studies that met inclusion criteria of 22,714 searched. Ninety-seven (10.1%) of included studies achieved Level 1 or 2 evidence, but case series (52.3%) were the most common. Collaboration occurred in 14.4% of studies and the vast majority of these (88.4%) were among academic institutions. Collaborative studies were more likely to be Level 1 or 2 (20.3% vs. 8.4%, p

Background: International orthopaedic resident rotations in low and middle-income countries (LMICs) are gaining popularity among high-income country (HIC) residency programs. While evidence demonstrates a benefit for the visiting residents, few studies have evaluated the impact of such rotations on the orthopaedic surgeons and trainees in LMICs. The purpose of this study was to further explore themes identified in a previous survey study regarding the local impact of visiting HIC resident rotations.Methods: Using a semistructured interview guide, LMIC surgeons and trainees who had hosted HIC orthopaedic residents within the previous 10 years were interviewed until thematic saturation was reached.Results: Twenty attending and resident orthopaedic surgeons from 8 LMICs were interviewed. Positive and negative effects of the visiting residents on clinical care, education, interpersonal relationships, and resource availability were identified. Seven recommendations for visiting resident rotations were highlighted, including a 1 to 2-month rotation length; visiting residents at the senior training level; site-specific prerotation orientation with an emphasis on resident attitudes, including the need for humility; creation of bidirectional opportunities; partnering with institutions with local training programs; and fostering mutually beneficial sustained relationships.Conclusions: This study explores the perspectives of those who host visiting residents, a viewpoint that is underrepresented in the literature. Future research regarding HIC orthopaedic resident rotations in LMICs should include the perspectives of local surgeons and trainees to strive for mutually beneficial experiences to further strengthen and sustain such academic partnerships. [ABSTRACT FROM AUTHOR]

Abstract: Globally, the burden of musculoskeletal conditions continues to rise, disproportionately affecting low and middle-income countries (LMICs). The ability to meet these orthopaedic surgical care demands remains a challenge. To help address these issues, many orthopaedic surgeons seek opportunities to provide humanitarian assistance to the populations in need. While many global orthopaedic initiatives are well-intentioned and can offer short-term benefits to the local communities, it is essential to emphasize training and the integration of local surgeon-leaders. The commitment to developing educational and investigative capacity, as well as fostering sustainable, mutually beneficial partnerships in low-resource settings, is critical. To this end, global health organizations, such as the Consortium of Orthopaedic Academic Traumatologists (COACT), work to promote and ensure the lasting sustainability of musculoskeletal trauma care worldwide. This article describes global orthopaedic efforts that can effectively address musculoskeletal care through an examination of 5 domains: clinical care, clinical research, surgical education, disaster response, and advocacy. [ABSTRACT FROM AUTHOR]

Background: Open fractures, especially of the tibia, require prompt intervention to achieve optimal patient outcomes. While open tibial shaft fractures are common injuries in low- and middle-income countries (LMICs), there is a dearth of literature examining delays to surgery for these injuries in low-resource settings. This study investigated risk factors for delayed management of open tibial fractures in Tanzania.Methods: We conducted an ad hoc analysis of adult patients enrolled in a prospective observational study at a tertiary referral center in Tanzania from 2015 to 2017. Multivariable models were utilized to analyze risk factors for delayed hospital presentation of ≥2 hours, median time from injury to the treatment hospital, and delayed surgical treatment of ≥12 hours after admission among patients with diaphyseal open tibial fractures.Results: Two hundred and forty-nine patients met the inclusion criteria. Only 12% of patients used an ambulance, 41% were delayed ≥2 hours in presentation to the first hospital, 75% received an interfacility referral, and 10% experienced a delay to surgery of ≥12 hours after admission. After adjusting for injury severity, having insurance (adjusted odds ratio [aOR] = 0.48; 95% confidence interval [CI] = 0.24 to 0.96) and wounds with approximated skin edges (aOR = 0.37; 95% CI = 0.20 to 0.66) were associated with a decreased risk of delayed hospital presentation. Interfacility referrals (2.3 hours greater than no referral; p = 0.015) and rural injury location (10.9 hours greater than urban location; p < 0.001) were associated with greater median times to treatment hospital admission. Older age (aOR = 0.54 per 10 years; 95% CI = 0.31 to 0.95), single-person households (aOR = 0.12 compared with ≥8 people; 95% CI = 0.02 to 0.96), and an education level greater than pre-primary (aOR = 0.16; 95% CI = 0.04 to 0.62) were associated with fewer delays to surgery of ≥12 hours after admission.Conclusions: Prehospital network and socioeconomic characteristics are associated with delays to open tibial fracture care in Tanzania. Reducing interfacility referrals and implementing surgical cost-reduction strategies may help to reduce delays to open fracture care in LMICs.Level Of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Despite a substantial burden of musculoskeletal injury, orthopaedic trauma studies in Latin America are lacking. The purpose of the present study was to identify research priorities among orthopaedic trauma surgeons in Latin America.Methods: Research questions were solicited from members of the Asociación de Cirujanos Traumatólogos de las Américas. Participants rated questions by importance from 1 to 9. All questions were redistributed with an aggregate rating, and participants rerated questions with knowledge of group responses.Results: Seventy-eight participants completed the first survey and were included in subsequent surveys. The mean age was 51.8 years, and most participants were male (92%), had completed an orthopaedic trauma fellowship (60.3%), and participated in research (80.8%). Seventeen countries were represented; 5 respondents were from a high-income country, 67 were from an upper middle-income country, and 6 were from a lower middle-income country. Sixty-five questions were identified. Six questions were rated from 1 to 3 ("more important") by >70% of participants: (1) What is the optimal treatment protocol for elderly patients with hip fracture? (2) What is the most effective initial and definitive management of musculoskeletal injury, including timing and surgical strategy, for the polytraumatized patient? (3) What is the ideal state of open fracture treatment, including timeliness and method of antibiotics, debridement, surgical fixation, and closure or coverage, at each hospital level in the health-care system? (4) What patient and fracture characteristics predict infection after musculoskeletal injury? (5) What is the current state of treatment for fracture-related infection, including timeliness and method of antibiotics and surgical intervention, at each hospital level in the health-care system? (6) What is the optimal protocol for temporary management for the hemodynamically unstable patient with a pelvic or acetabular fracture?Conclusions: This modified Delphi study of orthopaedic trauma surgeons in Latin America identified geriatric hip fractures, polytrauma, open fractures, musculoskeletal infection, and pelvic and acetabular fractures as top research priorities. This information is important for resource allocation and goal setting for orthopaedic trauma in the region. [ABSTRACT FROM AUTHOR]

Background: The rise of diabetes and traumatic injury has increased limb loss-related morbidity in low- and middle-income countries (LMICs). Despite this, the majority of amputees in LMICs have no access to prosthetic devices, and the magnitude of prosthesis impact on quality of life (QOL) and function has not been quantified. Objectives: Quantify the impact of prostheses on QOL and function in Tanzanian transfemoral amputees. Method: A prospective cohort study was conducted. Transfemoral amputees at Muhimbili Orthopaedic Institute were assessed twice before and three times after prosthetic fitting using EuroQol-5D-3L (EQ-5D-3L), Prosthetic Limb Users Survey of Mobility (PLUS-M), 2-minute walk test (2MWT) and Physiologic Cost Index (PCI). Data were analysed for change over time. Subgroup analysis was performed for amputation aetiology (vascular or non-vascular) and prosthesis use. Results: Amongst 30 patients, EQ-5D, PLUS-M and 2MWT improved after prosthesis provision (p < 0.001). EuroQol-5D increased from 0.48 to 0.85 at 1 year (p < 0.001). EuroQol-5D and 2MWT were higher in non-vascular subgroup (p < 0.030). At 1-year, 84% of non-vascular and 44% of vascular subgroups reported using their prosthesis (p = 0.068). Conclusion: Prosthesis provision to transfemoral amputees in an LMIC improved QOL and function. This benefit was greater for non-vascular amputation aetiologies. Quality of life and function returned to pre-prosthesis levels with discontinued use of prosthesis. [ABSTRACT FROM AUTHOR]

Background: Open tibial shaft fractures are an important source of disability in Latin America. High-income countries (HICs) worldwide have established standardized treatment protocols for open tibial fractures, but less is known about their treatment in middle-income countries (MICs) in Latin America. This survey of Latin American orthopaedic surgeons characterizes open tibial fracture treatment patterns.Methods: Orthopaedic surgeons from 20 national orthopaedic societies throughout Latin America completed an online survey assessing their treatment of open tibial fractures. Demographic information was collected. Treatment patterns were queried according to 2 groupings of Gustilo-Anderson (GA) fracture types: treatment of type-I and type-II fractures (GA-I/II) and treatment of type-III fractures (GA-III). Treatment patterns were evaluated across 4 domains: antibiotic prophylaxis, irrigation and debridement, fracture stabilization, and wound management. Summary statistics were reported; analysis was performed using the Fisher exact test (p < 0.05).Results: There were 616 survey participants from 20 Latin American countries (4 HICs and 16 MICs). Initial external fixation followed by staged internal fixation was preferred for GA-I/II (51.0%) and GA-III fractures (86.0%). Nearly one-third (31.5%) of GA-IIIB fractures did not receive a soft-tissue coverage procedure. Stratifying by country socioeconomic status, surgeons in MICs more commonly utilized delayed internal fixation for GA-I/II (53.3% versus 22.0%, p < 0.001) and GA-III fractures (94.0% versus 80.4%, p = 0.002). Surgeons in MICs more commonly used primary closure for GA-I/II (88.9% versus 62.8%, p < 0.001) and GA-III fractures (32.6% versus 9.8%, p < 0.001).Conclusions: This survey reports Latin American orthopaedic surgeons' treatment patterns for open tibial shaft fractures. Surgeons in MICs reported higher delayed internal fixation use for all fracture types, while surgeons in HICs more routinely avoid primary closure. Soft-tissue coverage procedures are not performed in nearly one-third of GA-IIIB fractures because of a lack of operative personnel and training. [ABSTRACT FROM AUTHOR]

Background: Treatment of diaphyseal open tibia fractures often results in reoperation and impaired quality of life. Few studies, particularly in resource-limited settings, have described factors associated with outcomes after these fractures.Questions/purposes: (1) Which patient demographic, perioperative, and treatment characteristics are associated with an increased risk of reoperation after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? (2) Which patient demographic, perioperative, and treatment characteristics are associated with worse 1-year quality of life after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania?Methods: A prospective study was completed in parallel to a similarly conducted RCT at a tertiary referral center in Tanzania that enrolled adult patients with diaphyseal open tibia fractures from December 2015 to March 2017. Patients were treated with either a statically locked intramedullary nail or external fixator and examined at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The primary outcome, reoperation, was any deep infection or nonunion treated with a secondary intervention. The secondary outcome was the 1-year EuroQol-5D (EQ-5D) index score. There were 394 patients screened and ultimately, 267 patients enrolled in the study (240 from the primary RCT and 27 followed for the purposes of this study). Of these, 90% (240 of 267) completed 1-year follow-up and were included in the final analysis. This group comprised 110 patients who underwent IMN and 130 who had external fixation; follow-up was similar between study groups. Patients were an average of 33 years old and were primarily males who sustained road traffic injuries resulting in AO/Orthopaedic Trauma Association (OTA) classification type A or B fractures. There were 51 reoperations. For the purposes of analysis, all patients were pooled to identify all other factors, in addition to treatment type, associated with increased risk of reoperation and 1-year quality of life. An exploratory bivariable analysis identifying various factors associated with reoperation risk and EQ-5D was subsequently included in a multivariate modeling procedure to control for confounding of effect on our primary outcome. Multivariable modeling was performed using standard hierarchical modeling simplification procedures with log-likelihood ratios. Alpha levels were set to 0.05.Results: After controlling for potentially confounding variables such as gender, smoking status, mechanism of injury, and treatment type, the following factors were independently associated with reoperation: Time from hospital presentation to surgery more than 24 hours (odds ratio 7.7 [95% confidence interval 2.1 to 27.8; p = 0.002), AO/OTA fracture classification Type 42C fracture (OR 4.2 [95% CI 1.2 to 14.0]; p = 0.02), OTA-Open Fracture Classification muscle loss (OR 7.5 [95% CI 1.3 to 42.2]; p = 0.02), and varus coronal angle on an immediate postoperative AP radiograph (OR 4.8 [95% CI 1.2 to 14.0]; p = 0.002). After again controlling for confounding variables such as gender, smoking status, mechanism of injury, and treatment type factors independently associated with worse 1-year EQ-5D scores included: Wound length ≥ 10 cm (ß = [change in EQ-5D score] -0.081 [95% CI -0.139 to -0.023]; p = 0.006), OTA-Open Fracture Classification muscle loss (ß = -0.133 [95% CI -0.215 to -0.051]; p = 0.002), and OTA-Open Fracture Classification bone loss (ß = -0.111 [95% CI -0.208 to -0.013]; p = 0.03). We observed a modest, but independent association between reoperation and worse 1-year EQ-5D scores (ß = -0.113 [95% CI -0.150 to -0.077]; p < 0.001).Conclusions: We found two potentially modifiable factors associated with the risk of reoperation: reducing time to surgical treatment and avoiding varus coronal angulation during definitive stabilization. Hospitals may be able to minimize time to surgery, and thus, reoperation, by increasing the number of available operative personnel and space and emphasizing the importance of open tibia fractures as an injury requiring emergent orthopaedic management. Given the lack of fluoroscopy in the study setting and similar settings, surgeons should emphasize appropriate fracture alignment, even into slight valgus, to avoid varus angulation and subsequent reoperation risk.Level Of Evidence: Level II, therapeutic study. [ABSTRACT FROM AUTHOR]

Background: Open tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.Methods: We conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).Results: Of the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).Conclusions: To our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Open tibial fractures have a high risk of infection that leads to chronic osteomyelitis, functional impairment, and limb loss. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there is limited data evaluating aminoglycoside antibiotics. Objective: To assess the feasibility of a clinical trial aimed to test the efficacy of local gentamicin in reducing the risk of fracture-related infection (FRI) after open tibial fracture. Methods: This study is a single-center pilot masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. All adult patients presenting with an open tibia fracture (Gustilo Anderson Types I, II or IIIA; OTA Type 42) were eligible for this study. Patients were excluded if time from injury to presentation was > 48 hours or time from injury to surgery was > 7 days. Participants were randomized intraoperatively after wound closure to receive gentamicin solution (treatment), or normal saline solution (control) injected at the fracture site. Patients, surgeons, outcome assessors, data collectors, and data analysts were all masked to treatment assignment. Follow-ups were completed at 2-weeks, 6-weeks, 3-months, 6- months, 9-months, and 1-year post-operatively. The primary feasibility outcomes were the rate of enrolment and retention. The primary clinical outcome was the occurrence of FRI. Secondary outcomes measured were the occurrence of non-union, unplanned fracture-related reoperations, EQ-5D score, FIX-IT sore, and modified RUST score. Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). Most of the study population were male (80%) with an average age of 34 (SD 12.3). The primary mechanism was road traffic injury (85%). Complete data were recorded at baseline and follow up for >95% of cases The rate of follow up at 6-weeks, 3-months, 6-months, 9- months and 1 year were 70%, 68%, 69%, 61% and 80%, respectively. There was no difference in adverse events, or any of the measured primary and secondary outcomes. Conclusion: This pilot study is among the first to evaluate locally administered gentamicin in open tibial fractures. Results indicate a rigorous clinical trial with acceptable rates of enrolment and follow up to address this topic is possible in this setting. We, therefore, plan to proceed with a well-powered definitive trial. [ABSTRACT FROM AUTHOR]

Background: The optimal treatment for femoral shaft fractures in low-resource settings has yet to be established, in part, because of a lack of data supporting operative treatment modalities. We aimed to determine the reoperation rate among femoral fractures managed operatively and to identify risk factors for reoperation at a hospital in a Sub-Saharan country.Methods: We conducted a prospective clinical study at a single tertiary care center in Tanzania, enrolling all skeletally mature patients with diaphyseal femoral fractures managed operatively from July 2012 to July 2013. Patients were followed at regular intervals for 1 year postoperatively. The primary outcome was a complication requiring reoperation for any reason. Secondary outcomes were scores on the EuroQol (EQ)-5D, radiographic union score for tibial fractures (RUST), and squat-and-smile test.Results: There were a total of 331 femoral fractures (329 patients) enrolled in the study, with a follow-up rate at 1 year of 82.2% (272 of 331). Among the patients with complete follow-up, 4 injuries were managed with plate fixation and 268 were managed with use of an intramedullary nail. The reoperation rate for plate fixation was 25% (1 of 4) compared with 5.2% (14 of 268) for intramedullary nailing (p = 0.204). As found in a multivariate logistic regression, a small nail diameter, a Winquist type-3 fracture pattern, and varus malalignment of proximal fractures were associated with reoperation. The mean EQ-5D score at 1 year was 0.95 for patients who did not require reoperation compared with 0.83 for patients who required reoperation (p = 0.0002).Conclusions: Intramedullary nailing for femoral shaft fractures was associated with low risk of reoperation and a nearly full return to baseline health-related quality of life at 1 year of follow-up. There are potentially modifiable risk factors for reoperation that can be identified and addressed through education and dissemination of these findings.Level Of Evidence: Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]