A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia).

Background: Open tibial fractures have a high risk of infection that can lead to severe morbidity. Antibiotics administered locally at the site of the open wound are a potentially effective preventive measure, but there are limited data evaluating aminoglycoside antibiotics. The objective of this study was to assess the feasibility of a clinical trial to test the efficacy of local gentamicin in reducing the risk of fracture-related infection after open tibial fracture. Methods: This study is a single-center, pilot, masked, randomized controlled trial conducted at the Muhimbili Orthopaedic Institute. Participants were randomized intraoperatively after wound closure to receive gentamicin solution or normal saline solution injected at the fracture site. Follow-ups were completed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year postoperatively. The primary feasibility outcomes were the rate of enrollment and retention. The primary clinical outcome was the occurrence of fracture-related infection. Results: Of 199 patients screened, 100 eligible patients were successfully enrolled and randomized over 9 months (11.1 patients/month). 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 enrollment and follow-up to address this topic is possible in this setting.

GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures.

BACKGROUND: The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different. METHODS: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up. DISCUSSION: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures. TRIAL REGISTRATION: Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

Reliability of Modified Radiographic Union Score for Tibia Scores in the Evaluation of Femoral Shaft Fractures in a Low-resource Setting.

INTRODUCTION: The modified Radiographic Union Score for Tibia (RUST) fractures was developed to better describe fracture healing, but its utility in resource-limited settings is poorly understood. This study aimed to determine the validity of mRUST scores in evaluating fracture healing in diaphyseal femur fractures treated operatively at a single tertiary referral hospital in Tanzania. METHODS: Radiographs of 297 fractures were evaluated using the mRUST score and compared with outcomes including revision surgery and EuroQol five dimensions questionnaire (EQ-5D) and visual analog scale (VAS) quality-of-life measures. Convergent validity was assessed by correlating mRUST scores with EQ-5D and VAS scores. Divergent validity was assessed by comparing mRUST scores in patients based on revision surgery status. RESULTS: The mRUST score had moderate correlation (Spearman correlation coefficient 0.40) with EQ-5D scores and weak correlation (Spearman correlation coefficient 0.320) with VAS scores. Compared with patients who required revision surgery, patients who did not require revision surgery had higher RUST scores at all time points, with statistically significant differences at 3 months (2.02, P < 0.05). DISCUSSION: These results demonstrate that the mRUST score is a valid method of evaluating the healing of femoral shaft fractures in resource-limited settings, with high interrater reliability, correlation with widely used quality of life measures (EQ-5D and VAS), and expected divergence in the setting of complications requiring revision surgery.

Risk Factors for Delayed Hospital Admission and Surgical Treatment of Open Tibial Fractures in Tanzania.

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.

Assessment of clinical and radiographic outcomes following retrograde versus antegrade nailing of infraisthmic femoral shaft fractures without the use of intraoperative fluoroscopy in Tanzania.

To compare clinical and radiographic outcomes following antegrade versus retrograde intramedullary nailing of infraisthmic femoral shaft fractures. DESIGN: Secondary analysis of prospective cohort study. SETTING: Tertiary hospital in Tanzania. PARTICIPANTS: Adult patients with infraisthmic diaphyseal femur fractures. INTERVENTION: Antegrade or retrograde SIGN intramedullary nail. OUTCOMES: Health-related quality of life (HRQOL), radiographic healing, knee range of motion, pain, and alignment (defined as less than or equal to 5 degrees of angular deformity in both coronal and sagittal planes) assessed at 6, 12, 24, and 52 weeks postoperatively. RESULTS: Of 160 included patients, 141 (88.1%) had 1-year follow-up and were included in analyses: 42 (29.8%) antegrade, 99 (70.2%) retrograde. Antegrade-nailed patients had more loss of coronal alignment (P = .026), but less knee pain at 6 months (P = .017) and increased knee flexion at 6 weeks (P = .021). There were no significant differences in reoperations, HRQOL, hip pain, knee extension, radiographic healing, or sagittal alignment. CONCLUSIONS: Antegrade nailing of infraisthmic femur fractures had higher incidence of alignment loss, but no detectable differences in HRQOL, pain, radiographic healing, or reoperation. Retrograde nailing was associated with increased knee pain and decreased knee range of motion at early time points, but this dissipated by 1 year. To our knowledge, this is the first study to prospectively compare outcomes over 1 year in patients treated with antegrade versus retrograde SIGN intramedullary nailing of infraisthmic femur fractures.Level of Evidence: III.

Intramedullary nailing versus external fixation for open tibia fractures in Tanzania: a cost analysis.

OBJECTIVES: Open tibia fractures pose a clinical and economic burden that is disproportionately borne by low-income countries. A randomized trial conducted by our group showed no difference in infection and nonunion comparing 2 treatments: external fixation (EF) and intramedullary nailing (IMN). Secondary outcomes favored IMN. In the absence of clear clinical superiority, we sought to compare costs between EF and IMN. DESIGN: Secondary cost analysis. SETTING: Single institution in Tanzania. PATIENTS/PARTICIPANTS: Adult patients with acute diaphyseal open tibia fractures who participated in a previous randomized controlled trial. INTERVENTION: SIGN IMN versus monoplanar EF. MAIN OUTCOME MEASUREMENTS: Direct costs of initial surgery and hospitalization and subsequent reoperation: implant, instrumentation, medications, disposable supplies, and personnel costs.Indirect costs from lost productivity of patient and caregiver.Societal (total) costs: sum of direct and indirect costs.All costs were reported in 2018 USD. RESULTS: Two hundred eighteen patients were included (110 IMN, 108 EF). From a payer perspective, costs were $365.83 (95% CI: $332.75-405.76) for IMN compared with $331.25 ($301.01-363.14) for EF, whereas from a societal perspective, costs were $2664.59 ($1711.22-3955.25) for IMN and $2560.81 ($1700.54-3715.09) for EF. The largest drivers of cost were reoperation and lost productivity. Accounting for uncertainty in multiple variables, probabilistic sensitivity analysis demonstrated that EF was less costly than IMN from the societal perspective in only 55% of simulations. CONCLUSIONS: Intramedullary nail fixation compared with external fixation of open tibia fractures in a resource-constrained setting is not associated with increased cost from a societal perspective.

The Initial Economic Burden of Femur Fractures on Informal Caregivers in Dar es Salaam, Tanzania.

Background: Femur fracture patients require significant in-hospital care. The burden incurred by caregivers of such patients amplifies the direct costs of these injuries and remains unquantified. Aim: Here we aim to establish the in-hospital economic burden faced by informal caregivers of femur fracture patients. Methods: 70 unique caregivers for 46 femoral shaft fracture patients were interviewed. Incurred economic burden was determined by the Human Capital Approach, using standardized income data to quantify productivity loss (in $USD). Linear regression assessed the relationship between caregiver burden and patient time-in-hospital. Results: The average economic burden incurred was $149, 9% of a caregiver's annual income and positively correlated with patient time in hospital (p<0.01). Conclusion: Caregivers of patients treated operatively for femur fractures lost a large portion of their annual income, and this loss increased with patient time in hospital. These indirect costs of femur fracture treatment constitute an important component of the total injury burden.

Evaluating reliability and validity of the modified radiographic union scale for tibia (mRUST) among North American and Tanzanian surgeons.

OBJECTIVES: To determine the international reliability and validity of the modified Radiographic Union Scale for Tibial fracture (mRUST) scoring method for open tibial shaft fractures based on ratings of radiographs by separate groups of North American and Tanzanian surgeons. METHODS: Seven North American and 9 Tanzanian surgeons viewed 100 pairs of AP and lateral radiographs of open tibial shaft fractures obtained in Dar Es Salaam, Tanzania. The radiographs showed 25 patients' fractures at 4 time points postfracture after treatment with either external fixation or intramedullary nailing. Surgeons evaluated each fracture using the mRUST scoring method and indicated their confidence that the fracture was healed on a scale from 1 to 10. Reliability of mRUST was determined using inter-rater agreement among North American and Tanzanian surgeons. Validity was determined via analysis of correlation between mRUST scores and EQ-5D-3L index scores at each time point postfracture. RESULTS: mRUST scores demonstrated strong reliability overall (ICC = 0.64) as well as within each group of North American (ICC = 0.72) and Tanzanian (ICC = 0.69) surgeons. Reliability was stronger for external fixation than for intramedullary nailing cases. mRUST scores were significantly correlated with overall healing confidence at all time points and with quality of life at 6 months and 1 year postfracture. mRUST scores also correlated significantly with patients' quality of life scores (EQ-5D index) at 6 months and 1 year postfracture. CONCLUSION: North American and Tanzanian surgeons exhibited strong agreement in rating open tibial shaft fractures. Using mRUST scores is a valid means of assessing radiographic healing of tibial fractures in austere environments like Tanzania.

A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania.

BACKGROUND: Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings. METHODS: We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures. DISCUSSION: The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, Registration # NCT03559400 ; Registered June 18, 2018.

Delays to Surgery and Coronal Malalignment Are Associated with Reoperation after Open Tibia Fractures in Tanzania.

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.

Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibial Fractures in Tanzania: Results of a Randomized Clinical Trial.

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.

Travel barriers, unemployment, and external fixation predict loss to follow-up after surgical management of lower extremity fractures in Dar es Salaam, Tanzania.

OBJECTIVE: Predict loss to follow-up in prospective clinical investigations of lower extremity fracture surgery. DESIGN: Secondary analysis of 2 prospective clinical trials. SETTING: National public orthopaedic and neurologic trauma tertiary referral hospital in Dar es Salaam, Tanzania, a low-income country in sub-Saharan Africa. PATIENTS/PARTICIPANTS: Three hundred twenty-nine femoral shaft and 240 open tibial shaft fracture patients prospectively enrolled in prospective controlled trials of surgical fracture management by external fixation, plating, or intramedullary nailing between June 2015 and March 2017. INTERVENTION: Telephone contact for failure to attend scheduled 1-year clinic visit. MAIN OUTCOME MEASUREMENTS: Ascertainment of primary trial outcome at 1-year from surgery; post-hoc telephone questionnaire for reasons patient did not attend the 1-year clinic visit. RESULTS: One hundred twenty-seven femur fracture (39%) and 68 open tibia fracture (28%) patients did not attend the 1-year clinic visit. Telephone contact significantly improved ascertainment of the primary study outcome by 20% between 6-month and 1-year clinic visits to 82% and 92% respectively at study completion. Multivariable analysis associated unemployment (OR = 2.5 [1.7-3.9], P < .001), treatment with an external fixator (OR = 1.7 [1.0-2.8], P = .033), and each additional 20 km between residence and clinic (OR = 1.03 [1.00-1.06], P = .047] with clinic nonattendance. One hundred eight (55%) nonattending patients completed the telephone questionnaire, reporting travel distance to the hospital (49%), and travel costs to the hospital (46%) as the most prevalent reasons for nonattendance. Sixty-five percent of patients with open tibia fractures cited relocation after surgery as a contributing factor. CONCLUSIONS: Relocation during recovery, travel distance, travel cost, unemployment, and use of an external fixator are associated with loss to clinical follow-up in prospective investigations of femur and open tibia fracture surgery in this population. Telephone contact is an effective means to assess outcome.

Surgical Implant Generation Network (SIGN) Fin nail versus SIGN standard intramedullary nail for distal diaphyseal femur fractures treated via retrograde approach.

INTRODUCTION: Surgical fixation of distal diaphyseal femur fractures remains a major challenge in developing countries given limited availability of fluoroscopy. The Surgical Implant Generation Network (SIGN) Standard Intramedullary Nail and SIGN Fin Nail are two modalities developed to address this challenge; the Fin Nail additionally avoids needing to place proximal interlocking screws. While efficacy of the Standard Nail has been established, outcomes following fixation with the Fin Nail are unknown. In this study, we compare outcomes of distal diaphyseal femur fractures treated with each implant. METHODS: A prospective cohort study was conducted from 2012 to 2013 at a single tertiary-referral center in Tanzania. Skeletally mature patients with distal diaphyseal femur fractures treated with either retrograde SIGN Standard Nail or Fin Nail were included. Patients followed-up at 6, 12, 26, and 52 weeks post-operatively. The primary outcome was all-cause reoperation. Secondary outcomes included infection, non-union, malalignment, quality of life (EQ-5D score), pain (VAS score), radiographic healing (RUST score), and function (pain with weight bearing, knee range of motion, and Squat and Smile score). RESULTS: 74 (85%) of 85 enrolled patients completed the minimum 1-year follow-up. There was no difference in rate of reoperation (p = 1.00), infection (p = 1.00), limb length discrepancy (p = 0.47), non-union (p = 1.00), or coronal or sagittal malalignment (p = 1.00, p = 0.55 respectively) at 1 year. There was furthermore no difference in mean EQ-5D (p = 0.82), VAS pain score (p = 0.43), RUST score (p = 0.44), maximum knee flexion (p = 0.52) and extension (p = 1.00), or Squat and Smile function (p = 1.00) between cohorts at 1 year. DISCUSSION: Outcomes associated with the SIGN Fin Nail are comparable to those associated with the SIGN Standard Intramedullary Nail at 1 year. The SIGN Fin Nail may be useful as an alternative to Standard locked IM nails for fixation of distal diaphyseal femur fractures.

The burden of femoral shaft fractures in Tanzania.

BACKGROUND: Road traffic injuries disproportionately affect low- and middle-income countries (LMICs) and are associated with femur fractures that lead to long-term disability. Information about these injuries is crucial for appropriate healthcare resource allocation. The purpose of this study is to estimate the incidence of femoral shaft fractures in Tanzania and describe the unmet surgical burden. METHODS: Study sites included six government hospitals across Tanzania. Investigators collected data from hospital admission and procedural logbooks to estimate femoral shaft fracture incidence and their treatment methods. Semi-quantitative interviews were conducted with relevant hospital personnel to validate estimates obtained from hospital records. Investigators gathered road traffic incident (RTI) statistics from national police reports and calculated femur fracture:RTI ratios. RESULTS: Femoral shaft fracture annual incidence rate ranged from 2.1 to 18.4 per 100,000 people. Median low and high femur fracture:RTI ratio were 0.54 and 0.73, respectively. At smaller hospitals, many patients (5-25%) were treated with traction, and a majority (70-90%) are referred to other centers. Barriers to surgery at each hospital include a lack of surgical implants, equipment, and personnel. CONCLUSIONS: The incidence rate is similar to previous estimations, and it is consistent with an increased femoral shaft fracture incidence in Tanzania when compared to higher income countries. The femur fracture:RTI ratio may be a valid tool for estimating femur fracture incidence rates. There is an unmet orthopaedic surgical burden for femur fractures treatment at rural hospitals in Tanzania, and the barriers to treatment could be targets for future interventions.

Conducting a Randomized Controlled Trial in Tanzania: Institute for Global Orthopaedics and Traumatology and the Muhimbili Orthopaedic Institute.

INTRODUCTION: Low- and middle-income countries (LMICs) experience a large volume of orthopaedic trauma, but limited research exists to evaluate effective treatments using locally available means. Academic partners can help design and implement research studies through collaborative efforts with local investigators. We will describe the study design and lessons learned from a randomized controlled trial in Tanzania comparing outcomes of 2 operative treatments for open tibia fractures. STUDY DESIGN: The Institute for Global Orthopaedics and Traumatology at the University of California, San Francisco, and the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, partnered to design a prospective, randomized controlled trial. Adult patients with open tibia fractures were randomized to receive either intramedullary nailing or external fixation as definitive fixation. Our primary outcome was the rate of reoperation, and secondary outcomes included EQ-5D, pain, function, radiographic union, and return to work. RESULTS: We enrolled 40 patients in a pilot study that informed improvements in the study design and standard operating procedures. These modifications included development of a specific outline of the technical standards for each surgical intervention and held training workshops to disseminate this knowledge among operative surgeons. This resulted in the successful enrollment and standardized treatment of our target sample of 240 patients. DISCUSSION: There are several challenges in conducting high-quality, international research. Keys for success include maintaining a strong relationship between partners, having local research coordinators, simplifying data collection and storage, and incentivizing patients to attend follow-up visits.

Predictors of lower health-related quality of life after operative repair of diaphyseal femur fractures in a low-resource setting.

BACKGROUND: Little data exists on the negative impact of orthopaedic trauma on quality of life (QOL) in low- and middle-income countries (LMICs). The goal of this study is to investigate the factors associated with lower QOL after operative fixation of femoral shaft fractures in adult patients in a low-resource setting. METHODS: This prospective cohort study followed 272 factures in adults undergoing operative fixation for diaphyseal femur fractures at Tanzania. Patient demographics, injury characteristics, treatment modalities, and functional outcomes up to 1-year post-operatively were evaluated for association with 1-year post-operative EQ-5D QOL scores via univariate linear regression analysis. RESULTS: EQ-5D values were significantly lower at 1 year than at baseline (0.941 vs 0.991, p < 0.0005). CONCLUSIONS: Operative fixation of femoral shaft fractures in LMICs results in return to near baseline QOL. Demographic and treatment factors were not significantly associated with EQ-5D. and several markers of recovery were associated with lower 1 year QOL, including pain, knee stiffness, delayed radiographic healing, complications requiring reoperation. Efforts to reduce perioperative complications may help improve post-operative QOL.

The impact of antegrade intramedullary nailing start site using the SIGN nail in proximal femoral fractures: A prospective cohort study.

INTRODUCTION: In many low and middle-income countries (LMICs) SIGN nail is commonly used for antegrade femoral intramedullary (IM) nailing, using a start site either at the tip of the greater trochanter or piriformis fossa. While a correct start site is considered an essential technical step; few studies have evaluated the impact of using an erroneous start site. This is particularly relevant in settings with limited access to fluoroscopy to aid in creating a nail entry point. The purpose of this study was to evaluate the impact of antegrade SIGN IM nailing start site on radiographic alignment and health-related quality of life. METHODS: In this prospective cohort study, adult patients with proximal femur fractures (OTA 32, subtrochanteric zone) treated with antegrade IM SIGN nail at Muhimbili Orthopaedic Institute (MOI), Dar es Salaam, Tanzania were enrolled. Start site was determined on the immediate postoperative X-ray and was graded on a continuous scale based on distance of the IM nail center from the greater trochanteric tip. The primary outcome measurement was coronal alignment on the post-operative x-ray. The secondary outcomes were reoperation rates, RUST scores and EQ5D scores at one year follow-up. RESULTS: Seventy-nine patients were enrolled. 50 of them (63.3%) had complete data at 1year and were included in the final data analysis. Of the fifty patients, nine (18%) had IM nails placed laterally, 26 (52%) medially and 15 (30%) directly over the tip of the greater trochanter. Compared to a start site at the tip or medial to the greater trochanter, a lateral start site was 9 times more likely to result in a varus malalignment (95% CI: 1.42-57.70, p=0.021). CONCLUSIONS: Lateral start site was associated with varus malalignment. Although lateral start site was not significantly associated with reoperation, varus deformity was associated with higher reoperation rates. Surgeons should consider avoiding a start site lateral to the tip of the greater trochanter or allow the nail to rotate to avoid malalignment when using the SIGN nail for proximal femur fractures.

Predictors of Reoperation for Adult Femoral Shaft Fractures Managed Operatively in a Sub-Saharan Country.

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.

The Cost of Intramedullary Nailing for Femoral Shaft Fractures in Dar es Salaam, Tanzania.

BACKGROUND: Femoral shaft fractures are one of the most common injuries seen by surgeons in low- and middle-income countries (LMICs). Surgical repair in LMICs is often dismissed as not being cost-effective or unsafe, though little evidence exists to support this notion. Therefore, the goal of this study is to determine the cost of intramedullary nailing of femoral shaft fractures in Tanzania. METHODS: We used micro-costing methods to estimate the fixed and variable costs of intramedullary nailing of femoral shaft fractures. Variable costs assessed included medical personnel costs, ward personnel costs, implants, medications, and single-use supplies. Fixed costs included costs for surgical instruments and administrative and ancillary staff. RESULTS: 46 adult femoral shaft fracture patients admitted to Muhimbili Orthopaedic Institute between June and September 2014 were enrolled and treated with intramedullary fixation. The total cost per patient was $530.87 (SD $129.99). The mean variable cost per patient was $419.87 (SD $129.99), the largest portion coming from ward personnel $144.47 (SD $123.30), followed by implant $134.10 (SD $15.00) medical personnel $106.86 (SD $28.18), and medications/supplies $30.05 (SD $12.28). The mean fixed cost per patient was $111.00, consisting of support staff, $103.50, and surgical instruments, $7.50. CONCLUSIONS: Our study provides empirical information on the variable and fixed costs of intramedullary nailing of femoral shaft fractures in LMICs. Importantly, the lack of surgical capacity was the primary driver of the largest cost for this procedure, preoperative ward personnel time. Our results provide the cost data for a formal cost-effectiveness analysis on this intervention.