Trial reportEuropean journal of trauma and emergency surgery : official publication of the European Trauma Society2026
Closed reduction and percutaneous fixation versus open reduction and internal fixation for displaced medial malleolar fractures: a randomized controlled trial.
Trial report in European journal of trauma and emergency surgery : official publication of the European Trauma Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
Funding
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Abstract
objectiveTo evaluate the radiographic and functional outcomes of closed reduction and percutaneous fixation (CRPF) compared to open reduction and internal fixation (ORIF) in the treatment of isolated displaced medial malleolar fractures.
methodsThis randomized controlled trial included 50 adult patients with isolated displaced medial malleolar fractures, Herscovici classification type B and C, across two hospitals. Participants were randomly assigned (1:1) to either CRPF (Group A, n = 25) or ORIF (Group B, n = 25). The principal objectives were radiological union and clinical function evaluated by the American Orthopedic Foot and Ankle Society (AOFAS) score at a 6-month follow-up. Secondary outcomes included the incidence of postoperative complications and correlations with patient demographics and mechanism of injury.
resultsAt 6 months, there was no significant difference between groups (p > 0.05); in Group A, 13 patients rated as "Good," 11 as "Fair," and 1 as "Poor," while in Group B, 15 were "Good," 9 "Fair," and 1 "Poor." AOFAS outcomes showed 13 excellent, 7 good, 4 fair, and 1 poor in Group A, versus 12 excellent, 9 good, 3 fair, and 1 poor in Group B, with no significant difference (p > 0.05). Complication rates were similar: wound infection (CRPF 4% vs. ORIF 12%), malunion/non-union (8% vs. 4%), hardware discomfort (12% vs. 20%), and deep venous thrombosis (4% vs. 12%). Comorbidities like diabetes and hypertension were significantly associated with increased sequelae risk (p < 0.05).
conclusionIn this randomized study, CRPF and ORIF demonstrated comparable observed clinical and radiological outcomes at six months. However, because no formal sample size calculation or equivalence margin was prespecified, these findings should not be interpreted as evidence of statistical equivalence. Larger adequately powered trials with longer follow-up are required.
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