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.
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.
Introduction: Open tibia fractures are some of the most common types of Orthopedics injuries in low- and middle-income countries (LMICs). In Tanzania, open tibia fractures are treated either conservatively by prolonged cast or surgically by external fixation (EF) or intramedullary nail (IMN) when available. The cost of treatment and amount of time patients spend away from work are major economic concerns with prolonged casting and EF. The goal of this study was to determine the cost effectiveness of IMN versus EF in the treatment of open diaphyseal tibia fractures at Muhimbili Orthopaedic Institute (Dar es Salaam, Tanzania). Methods: This is a prospective randomized control study conducted of patients with a closeable AO/OTA 42 open diaphyseal tibia fracture. The patients underwent surgical fixation with either IMN or EF at Muhimbili Orthopaedic Institute (MOI), and were followed up at 2, 6, and 12 weeks postoperatively. A micro-costing method was used to estimate the fixed and variable costs of IMN and EF of the open diaphyseal tibial fracture. Results: The mean total cost per patient was lower for the IMN group ($425.8 ± 38.4) compared to the EF group ($559.6 ± 70.5, p < 0.001), with savings of $133.80 per patient for the IMN group. The mean hospital stay was 2.72 ± 1.40 days for the IMN group and 2.44 ± 1.47 days for the EF group (p = 0.5). Quality-adjusted life years (QALYs) were 0.26 per patient for the IMN group and 0.24 in the EF group at 12 weeks (p = 0.8). Ninety-two percent of patients in the IMN group achieved fracture union versus 60% in the EF group at three months postoperatively (p = 0.03). Conclusion: IM nailing of a closeable open diaphyseal tibial fracture is more cost effective than EF. In addition, IM nailing has better union rates at three months compared to EF.
Introduction: Traumatic lower extremity injuries requiring multidisciplinary treatment pose a challenge in low- and middle-income countries, where access to specialists may be limited. The surgical management and reconstructive training (SMART) course teaches orthopaedic surgeons muscle and fasciocutaneous flap procedures to address this scarcity. The purpose of this study is to assess the effectiveness of the SMART course in improving competency and comfort in performing common lower extremity flap procedures among participants. Methods: Sixty-four orthopaedic surgeons from different regions of Nepal and Bhutan participated in the Nepal SMART course in 2016 and 2017. A competency test—consisting of questions from US in-training plastic and orthopaedic surgery examinations—was administered to attendees before and after the course. Thirty-two participants from 2016 were asked to rate their comfort level in performing flap procedures both pre- and postcourse. Results: Overall competency test scores, as well as scores in the plastic surgery section, increased significantly after the course (P < 0.01). The precourse competency test scores were higher in 2016 compared with 2017 (P = 0.02). There was a higher increase in overall competency test scores after the course in 2016 compared with 2017 (P = 0.03). The procedure comfort levels reported by attendees increased for all flaps (P < 0.01). Conclusions: These results demonstrate the ability of the SMART course to improve the competency and comfort levels of orthopaedic surgeons in performing common lower extremity flap procedures. Despite the differences in years in practice and previous experience in performing flaps, the course yielded significantly better results in 2017 compared with 2016, showing that the implementation of the course has been improving.
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