Best Practices for Developing International Academic Partnerships in Orthopaedics.

ABSTRACT: Traumatic and nontraumatic orthopaedic conditions are major contributors to global morbidity and account for the majority of life-years lived with disability worldwide. Additionally, the burden of musculoskeletal injuries has increased substantially over the past 3 decades. Unfortunately, in low and middle-income countries (LMICs), access to orthopaedic care is limited, leading to a disproportionate burden of disease. The Lancet Commission on Global Surgery has emphasized the urgent need for unified international commitment and research collaboration to achieve universal access to safe and affordable surgical care. However, conducting high-quality orthopaedic research in LMICs remains challenging as a result of disparities in training, access to resources, infrastructure, and equipment availability. Partnerships between high-income countries (HICs) and LMICs have emerged in recent decades as an effective approach to combatting some of these challenges. These partnerships aim to bridge the gaps by facilitating collaborative research and knowledge exchange. The establishment of successful partnerships requires a collaborative and reciprocal approach that starts with a clear understanding of mutual research aims and the availability of resources. Despite the potential benefits, various factors can make establishing such partnerships difficult. However, these partnerships can have a substantial impact in delivering quality orthopaedic education and research training, thus improving access to care in resource-limited environments. This paper represents the collaborative effort of multiple international academic orthopaedic surgeons with extensive experience in HIC-LMIC partnerships. Our aims were to outline the best practices for conducting orthopaedic research within these relationships and to provide guidance for future successful collaborations.

Determining Critical Topics for Undergraduate Surgical Education in Rwanda: Results of a Modified Delphi Process and a Consensus Conference.

Background Developing a contextually appropriate curriculum is critical to train physicians who can address surgical challenges in sub-Saharan Africa. An innovative modified Delphi process was used to identify contextually optimized curricular content to meet sub-Saharan Africa and Rwanda's surgical needs. Methods Participants were surgeons from East, Central, Southern, and West Africa and general practitioners with surgical experience. Delphi participants excluded or prioritized surgical topic areas generated from extensive grey and formal literature review. Surgical educators first screened and condensed identified topics. Round 1 screened and prioritized identified topics, with a 75% consensus cut-off based on the content validity index and a prioritization score. Topics that reached consensus were screened again in round 2 and re-prioritized, following controlled feedback. Frequencies for aggregate prioritization scores, experts in agreement, item-level content validity index, universal agreement and scale-level content validity index based on the average method (S-CVI/Ave) using proportion relevance, and intra-class correlation (ICC) (based on a mean-rating, consistency, two-way mixed-effects model) were performed. We also used arithmetic mean values and modal frequency. Cronbach's Alpha was also calculated to ascertain reliability. Results were validated through a multi-institution consensus conference attended by Rwanda-based surgical specialists, general practitioners, medical students, surgical educators, and surgical association representatives using an inclusive, participatory, collaborative, agreement-seeking, and cooperative, a priori consensus decision-making model. Results Two-hundred and sixty-seven broad surgical content areas were identified through the initial round and presented to experts. In round 2, a total of 247 (92%) content areas reached 75% consensus among 31 experts. Topics that did not achieve consensus consisted broadly of small intestinal malignancies, rare hepatobiliary pathologies, and transplantation. In the final round, 99.6% of content areas reached 75% consensus among 31 experts. The highest prioritization was on wound healing, fluid and electrolyte management, and appendicitis, followed by metabolic response, infection, preoperative preparation, antibiotics, small bowel obstruction and perforation, breast infection, acute urinary retention, testicular torsion, hemorrhoids, and surgical ethics. Overall, the consistency and average agreement between panel experts was strong. ICC was 0.856 (95% CI: 0.83-0.87). Cronbach's Alpha for round 2 was very strong (0.985, 95% CI: 0.976-0.991) and higher than round 1, demonstrating strong reliability. All 246 topics from round 4 were verbally accepted by 40 participants in open forum discussions during the consensus conference. Conclusions A modified Delphi process and consensus were able to identify essential topics to be included within a highly contextualized, locally driven surgical clerkship curriculum delivered in rural Rwanda. Other contexts can use similar processes to develop relevant curricula.

Outcomes of Intramedullary Nailing and External Fixation of Open Tibial Fractures: Three to Five-Year Follow-up of a Randomized Clinical Trial.

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.

Host Perspectives of High-Income Country Orthopaedic Resident Rotations in Low and Middle-Income Countries.

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.

Establishing Sustainable Arthroscopy Capacity in Low- and Middle-Income Countries (LMICs) through High-Income Country/LMIC Partnerships: A Qualitative Analysis.

Disparities exist in treatment modalities, including arthroscopic surgery, for orthopaedic injuries between high-income countries (HICs) and low- and middle-income countries (LMICs). Arthroscopy training is a self-identified goal of LMIC surgeons to meet the burden of musculoskeletal injury. The aim of this study was to determine the necessary "key ingredients" for establishing arthroscopy centers in LMICs in order to build capacity and expand training in arthroscopy in lower-resource settings. Methods: This study utilized semi-structured interviews with orthopaedic surgeons from both HICs and LMICs who had prior experience establishing arthroscopy efforts in LMICs. Participants were recruited via referral sampling. Interviews were qualitatively analyzed in duplicate via a coding schema based on repeated themes from preliminary interview review. Subgroup analysis was conducted between HIC and LMIC respondents. Results: We identified perspectives shared between HIC and LMIC stakeholders and perspectives unique to 1 group. Both groups were motivated by opportunities to improve patients' lives; the LMIC respondents were also motivated by access to skills and equipment, and the HIC respondents were motivated by teaching opportunities. Key ingredients identified by both groups included an emphasis on teaching and the need for high-cost equipment, such as arthroscopy towers. The LMIC respondents reported single-use materials as a key ingredient, while the HIC respondents reported local champions as crucial. The LMIC respondents cited the scarcity of implants and shaver blades as a barrier to the continuity of arthroscopy efforts. Conclusions: Incorporation of the identified key ingredients, along with leveraging the motivations of the host and the visiting participant, will allow future international arthroscopy partnerships to better match proposed interventions with the host-identified needs. Clinical Relevance: Arthroscopy is an important tool for treatment of musculoskeletal injury. Increasing access to arthroscopy is an important goal to achieve greater equity in musculoskeletal care globally. Developing successful partnerships between HICs and LMICs to support arthroscopic surgery requires sustained relationships that address local needs.

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.

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.

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.

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.

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.

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

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