Trial reportBMJ (Clinical research ed.)2026
Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial.
Trial report in BMJ (Clinical research ed.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01758796 (A Prospective Randomized Non-inferiority Trial to Compare Operative Versus Non-operative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomized Non-inferiority Trial to Compare Operative Versus Non-operative Treatment for ER-stress Positive Weber-B Unimalleolar Fractures
Who cites it
2 citing papers in PubMed.
- The Diagnosis, Treatment, and Aftercare of Ankle Fractures.Deutsches Arzteblatt international · 2026Review
- Impact of Initial Immobilization Method on Outcomes in Unstable Weber B Ankle Fractures: A Retrospective Cohort Study.Foot & ankle orthopaedics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare cast immobilisation with surgery using open reduction and internal plate fixation for unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing.
designRandomised, pragmatic, non-inferiority, clinical trial.
settingOne specialist university hospital trauma centre in Finland, 16 January 2013 to 7 July 2021.
participants840 skeletally mature patients (age ≥16 years) with an isolated Weber B fibula fracture on static radiographs. Fracture instability was assessed by standard external rotation stress test under fluoroscopy. 714 participants were excluded (569 with stable fracture, mortise incongruency, or fracture dislocation) and the remaining 126 patients with a congruent but unstable ankle mortise were randomised.
interventionsParticipants were randomly allocated to receive either conventional cast immobilisation for six weeks (n=62) or surgical treatment with open reduction and internal plate fixation followed by cast immobilisation for six weeks (n=64).
main outcome measuresThe primary, non-inferiority outcome was the Olerud-Molander Ankle Score (OMAS; range 0-100 points; higher scores indicating better outcomes and fewer symptoms) at two years. The predefined non-inferiority margin for the primary outcome was set at -8 points. Secondary outcomes were ankle function, pain, health related quality of life, ankle range of motion, and radiographic outcome. Treatment related adverse events were also recorded.
results121 out of 126 randomised participants (96%) completed the study. In the primary intention-to-treat analysis of 121 participants completing two year follow-up, the mean OMAS was 89 in the cast immobilisation group and 87 in the surgery group (between group mean difference 1.3 points, 95% confidence interval -4.8 to 7.3). No statistically significant between group differences were observed in any secondary outcomes. One participant in each group had radiographic evidence of non-union. In the surgery group, one participant had a superficial wound infection, one had delayed wound healing, and nine underwent procedures to remove hardware, two of whom developed postoperative infections (one deep and one superficial).
conclusionsCast immobilisation proved non-inferior to surgery for the treatment of unimalleolar Weber B ankle fractures with a congruent mortise on initial radiography but deemed unstable by external rotation stress testing. Overall, fewer treatment related harms occurred with cast immobilisation compared with surgery.
trial registrationClinicalTrials.gov NCT01758796.
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