Trial reportArchives of orthopaedic and trauma surgery2025
Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial.
Trial report in Archives of orthopaedic and trauma surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06883435 (A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures), which is not on this map. Not yet cited in PubMed.
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A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures
Who cites it
0 citing papers in PubMed.
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Corrections and comments
- Erratum issued
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIsolated medial malleolar (MM) fractures are infrequent injuries. Studies focused on their treatment are scarce. The aim of this study was to compare functional and radiographic outcomes of two surgical techniques for treatment of displaced isolated MM fractures in adults: closed reduction and percutaneous fixation (CRPF), and open reduction and internal fixation (ORIF) by using same implant; two partially-threaded cannulated cancellous screws. MATERIALS AND
methodsA prospective randomized controlled clinical trial (RCT) was conducted on 50 patients with isolated displaced MM fractures, treated with CRPF (group A) or ORIF (group B), at orthopaedics department of university hospital, from April 2021 to April 2023. Fractures were classified by Herscovici classification. The primary outcomes were incidence of complications and time to union based on radiographic assessment by plain radiographs of ankle. The secondary outcomes were functional assessment by Foot and Ankle Ability Measure (FAAM) for activities of daily living (ADLs) and sports, American Orthopaedic Foot and Ankle Society (AOFAS) score, and VAS.
resultsNo significant differences were noticed among two groups regarding age, sex, side affected, mechanism of injury, smoking, Herscovici classification, or follow-up duration. Mean final FAAM-ADLs was 97.6 ± 2 in group A, and 95 ± 3.4 in group B, (P = 0.155). Mean final FAAM-sports was 87 ± 11.4 in group A, and 73.4 ± 15.6 in group B, (P = 0.312). Mean final AOFAS score was 95.9 ± 8.4 in group A, and 94.6 ± 9.5 in group B, (P = 0.237). Mean final VAS for pain was 0.9 ± 0.5in group A, and 1.5 ± 0.9 in group B, (P = 0.453). Mean time of solid radiographic union was 9.5 ± 2 weeks in group A, and 10.4 ± 3 weeks in group B, (P = 0.026).
conclusionCRPF of displaced isolated MM fractures is an efficient method with comparable radiographic and functional outcomes to ORIF. Based on these results, percutaneous fixation could be a good alternative for managing displaced isolated MM fractures. LEVEL OF EVIDENCE: Level II therapeutic: Prospective randomized controlled clinical trial.
trial registrationThe trial was registered at www. CLINICALTRIALS: gov (Trial Registration Number: NCT06883435).
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