No Difference Between Intramedullary Kirschner-Wires and Titanium Elastic Nails in Treating Pediatric Femur Fractures: Results From a Randomized Clinical Trial in Dar Es Salaam, Tanzania
Abstract
Background: Femur fractures are a common cause of disability of children in low-and middle-income countries (LMICs). The introduction of flexible intramedullary nails improved the care of children with diaphyseal femoral fractures. Application of intramedullary nails is challenging in resource-limited settings due to implant cost and availability. Intramedullary Kirschner-wire (K-wire) fixation has been proposed as a low-cost alternative option for pediatric femur fractures. This study examines the non-inferiority of intramedullary K-wire to titanium elastic nail (TEN) for diaphyseal pediatric femur fractures.
Methods: A randomized clinical trial was performed at a tertiary orthopaedic center in Dar es Salaam, Tanzania. Children (5-14 years) with acute diaphyseal femur fractures were randomly assigned to intramedullary K-wire or TEN fixation. The primary outcome was malunion. Secondary outcomes included modified RUST score (mRUST), PedsQL questionnaire, squat depth, and complications.
Results: Of the 61 patients (33 K-wire, 28 TEN), 83% completed 1-year follow-up. This trial enrolled 61 of 160 planned patients (38% of target enrollment) and was therefore underpowered to establish non-inferiority. There were 5 cases of malunion (3 K-wire, 2 TEN; Risk difference 0.034, 95% CI -0.122-0.191, P = .52). No statistically significant difference was detected in mRUST score at 1-year follow-up (K-wire 16.00 vs. TEN 16.00, P-value = .38). Reoperation was required in 3 K-wire patients…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 160 participants or records.
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