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Three week versus six week #immobilisation for stable Weber B type ankle #fractures: randomised, multicentre, non-inferiority clinical trial
https://www.bmj.com/content/364/bmj.k5432
212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval −1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (−4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of −8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.
Conclusion Immobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture.
Three week versus six week #immobilisation for stable Weber B type ankle #fractures: randomised, multicentre, non-inferiority clinical trial
https://www.bmj.com/content/364/bmj.k5432
212 of 247 randomised participants (86%) completed the study. At 52 weeks, the mean OMAS was 87.6 (SD 18.3) in the six week cast group, 91.7 (SD 12.9) in the three week cast group, and 89.8 (SD 18.4) in the three week orthosis group. The between group difference at 52 weeks for the three week cast versus six week cast was 3.6 points (95% confidence interval −1.9 to 9.1, P=0.20), and for the three week orthosis versus six week cast was 1.7 points (−4.0 to 7.3, P=0.56). In both comparisons, the confidence intervals did not include the predefined inferiority margin of −8.8 points. The only statistically significant between group differences observed in the secondary outcomes and harms in the two primary comparisons were slight improvement in ankle plantar flexion and incidence of deep vein thrombosis, both in the three week orthosis group versus six week cast group.
Conclusion Immobilisation for three weeks with a cast or orthosis was non-inferior to conventional cast immobilisation for six weeks in the treatment of an isolated stable Weber B type fracture.