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.

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.

Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma.

Importance: Numerous studies have demonstrated that long-term outcomes after orthopedic trauma are associated with psychosocial and behavioral health factors evident early in the patient's recovery. Little is known about how to identify clinically actionable subgroups within this population. Objectives: To examine whether risk and protective factors measured at 6 weeks after injury could classify individuals into risk clusters and evaluate whether these clusters explain variations in 12-month outcomes. Design, Setting, and Participants: A prospective observational study was conducted between July 16, 2013, and January 15, 2016, among 352 patients with severe orthopedic injuries at 6 US level I trauma centers. Statistical analysis was conducted from October 9, 2017, to July 13, 2018. Main Outcomes and Measures: At 6 weeks after discharge, patients completed standardized measures for 5 risk factors (pain intensity, depression, posttraumatic stress disorder, alcohol abuse, and tobacco use) and 4 protective factors (resilience, social support, self-efficacy for return to usual activity, and self-efficacy for managing the financial demands of recovery). Latent class analysis was used to classify participants into clusters, which were evaluated against measures of function, depression, posttraumatic stress disorder, and self-rated health collected at 12 months. Results: Among the 352 patients (121 women and 231 men; mean [SD] age, 37.6 [12.5] years), latent class analysis identified 6 distinct patient clusters as the optimal solution. For clinical use, these clusters can be collapsed into 4 groups, sorted from low risk and high protection (best) to high risk and low protection (worst). All outcomes worsened across the 4 clinical groupings. Bayesian analysis shows that the mean Short Musculoskeletal Function Assessment dysfunction scores at 12 months differed by 7.8 points (95% CI, 3.0-12.6) between the best and second groups, by 10.3 points (95% CI, 1.6-20.2) between the second and third groups, and by 18.4 points (95% CI, 7.7-28.0) between the third and worst groups. Conclusions and Relevance: This study demonstrates that during early recovery, patients with orthopedic trauma can be classified into risk and protective clusters that account for a substantial amount of the variance in 12-month functional and health outcomes. Early screening and classification may allow a personalized approach to postsurgical care that conserves resources and targets appropriate levels of care to more patients.