Unreamed Intramedullary Nailing Versus External Fixation for the Treatment of Open Tibial Shaft Fractures in Uganda: A Randomized Clinical Trial.

OBJECTIVE: To compare unreamed intramedullary nailing versus external fixation for the treatment of Gustilo-Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda. DESIGN: Randomized clinical trial. SETTING: Regional referral hospital in Uganda. PATIENTS: Fifty-five skeletally mature patients with a Gustilo-Anderson type II or IIIA open tibia shaft fracture treated within 24 hours of injury between May 2016 and December 2019. INTERVENTION: Unreamed intramedullary nailing (n = 31) versus external fixation (n = 24). MAIN OUTCOME MEASUREMENTS: The primary outcome was function within 12 months of injury, measured using the Function IndeX for Trauma (FIX-IT) score. Secondary outcomes included health-related quality of life (HRQoL) using the 3-level version of the 5-dimension EuroQol instrument (EQ-5D-3L), radiographic healing using the Radiographic Union Scale for Tibia (RUST) fractures score, and clinical complications. RESULTS: Treatment with an intramedullary nail resulted in a 1.0-point higher [95% credible intervals (CrI), 0.1 to 1.9] FIX-IT score compared with external fixation. Results were similar for the secondary patient-reported outcomes, EQ-5D-3L and the visual analog scale component of the EuroQol instrument (EQ-VAS). RUST scores were not different between groups at any time point. Treatment with an intramedullary nail was associated with a 22.1% (95% CrI, -42.6% to 1.7%) lower rate of malunion and a 20.8% (95% CrI, -44.0% to 2.9%) lower rate of superficial infection. CONCLUSION: In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, although there is likely an important reduction in malunion and superficial infection. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Adverse events in the treatment of motorcycle-related isolated limb injuries at a regional hospital in Uganda: a prospective clinical analysis.

PURPOSE: Although motorcycle accidents are a leading cause of limb injury in Uganda, little is known about injury care quality at regional hospitals. This study measured the incidence of clinical adverse events (CAEs) and identified associated treatment barriers surrounding motorcycle-related isolated limb injuries at a regional hospital. METHODS: A prospective descriptive study was conducted among patients with motorcycle-related isolated limb injuries at a Ugandan regional hospital between September 2017 and February 2018. Patients were surveyed upon admission and monitored throughout their course of treatment. Weight-bearing status and quality of life measures (EQ-5D) were assessed at four and 12 weeks. RESULTS: One hundred twenty-four participants enrolled. Of the total participants, 12% refused definitive treatment. Among 108 treated patients, six experienced CAEs: four wound infections, one amputation, and one death. At 12 weeks follow-up, the majority of patients had no difficulty with mobility, pain/discomfort, or self-care, but 51% endorsed challenges completing certain daily chores, and 40% of patients could ambulate without an assistive device with restoration of pre-fracture gait. Both longer hospital stays and poorer 12-week functional recovery were seen among patients sustaining open fracture (p < 0.001). CONCLUSION: Treatment of isolated limb injuries at a Ugandan Regional Hospital was associated with minimal short-term CAEs. However, patients with more severe injuries may be at risk for delayed post-operative recovery. Future studies measuring long-term functional outcomes should be performed to better understand and optimize injury care in this population.

The Feasibility of a Randomized Controlled Trial for Open Tibial Fractures at a Regional Hospital in Uganda.

BACKGROUND: The inclusion of low and middle-income country (LMIC) hospitals in multicenter orthopaedic trials expands the pool of eligible patients and improves the external validity of the evidence. Furthermore, promoting studies in LMIC hospitals defines the optimal treatments for low-resource settings, the conditions under which the majority of musculoskeletal injuries are treated. The objective of this study was to determine the feasibility of a randomized controlled trial comparing external fixation with intramedullary (IM) nailing in patients with an isolated open tibial fracture who presented to a regional hospital in Uganda. METHODS: From July 2016 to July 2017, skeletally mature patients who presented to a Ugandan regional hospital with an isolated Gustilo-Anderson type-II or IIIA open fracture of the tibial shaft were eligible for inclusion. The primary feasibility outcomes were the enrollment rate, the recruitment rate, and the 3 and 12-month follow-up rates. The secondary outcomes included a comparison of 3 and 12-month follow-up rates between the treatment arms and a qualitative assessment of barriers to enrollment, timely treatment, and missed follow-up. RESULTS: During the 12-month enrollment period, 37.5% (30 of 80) of eligible patients were successfully enrolled and operatively treated on the basis of their random allocation, with an enrollment rate of 2.5 patients per month. Of the 30 enrolled patients, 53% completed their 3-month follow-up appointment, and 40% completed their 1-year follow-up appointment. Rates of 1-year follow-up were significantly higher for patients receiving IM nails than for those receiving external fixation (absolute difference, 52%; 95% confidence interval [CI], 21 to 83, p < 0.01). The main reasons that patients declined to participate in the trial were preferences for treatment by traditional bonesetters and prehospital delays that were related to a disorganized referral system. Barriers to follow-up included prohibitive transportation costs and community pressure to turn to traditional forms of treatment. CONCLUSIONS: A regional hospital in Uganda can successfully enroll, randomize, and operatively treat multiple patients with an open tibial fracture each month. Patient follow-up presents substantial concerns over trial feasibility in this setting. Cultural pressure to utilize traditional treatments remains a particularly common barrier to study-participant enrollment and retention.