Early versus delayed weight-bearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomised controlled trial.

作者：C. Bretherton, J. Achten, Vidoushee Jogarah, Stavros Petrou, Nicholas Peckham, Felix Achana, D. Appelbe, R. Kearney, Harry Claireux, P. Bell, X. Griffin, Andrew McAndrew, N. Jacobs, J. Forder, T. Hester, C. Cross, T. Bateman, W. Kieffer, Tristan Barton, Richard Walter, N. Savva, D. Marsland, Barry Rose, Zine Beech, Togay Koç, Bethany Armstead, Ben J Ollivere, Owen Diamond, Kar Teoh, Paul Magill, J. Mangwani, P. Hodgson, Robbie Ray, Baljinder S. Dhinsa, H. Majeed, J. Wong-Chung, J. Young, Agnes Lagare, A. Soogumbur, A. Morozova, Alexander Hunt, A. Adamson, Angie Dempster, Anne McCormack, A. Arif, C. Vye, Chetan Dojode, C. Brown, C. Haines, Christopher To, C. Brennan, Dan Winson, E. McGough, E. Jessup-Dunton, Fiona Bintcliffe, Fiona Thompson, Gabriel Omogra, Geo Scott, Helen Samuel, Hossam Fraig, Ina Burokiene, I. Odysseos-Beaumont, J. Rand, Janet Edkins, Joe Barrett-Lee, J. Mcfall, K. Wahed, Kate Herbert, K. Death, L. Beddard, L. Dupley, Leeann Bryce, L. Wright, L. Bailey, L. Maling, M. Raad, Matt Morris, Matthew Williams, M. Labidi, Natal Holmes, N. Staines, P. Matthews, P. McCormac, Rashmi Easow, S. Matthews, Smriti Kapoor, Sophie Harris, S. Wagland, T. Cobb, T. White · 发表于：The Lancet · 年份：2024 · DOI：10.1016/s0140-6736(24)00710-4 · 被引用次数：52 · 研究领域：Medicine

BACKGROUND After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy. METHODS This was a pragmatic, multicentre, randomised, non-inferiority trial including 561 participants (aged ≥18 years) who received acute surgery for an unstable ankle fracture in 23 UK National Health Service (NHS) hospitals who were assigned to either a delayed weight-bearing (n=280) or an early weight-bearing rehabilitation strategy (n=281). Patients treated with a hindfoot nail, those who did not have protective ankle sensation (eg, peripheral neuropathy), did not have the capacity to consent, or did not have the ability to adhere to trial procedures were excluded. Neither participants nor clinicians were masked to the treatment. The primary outcome was ankle function measured using the Olerud and Molander Ankle Score (OMAS) at 4 months after randomisation, in the per-protocol population. The pre-specified non-inferiority OMAS margin was -6 points and superiority testing was included in the intention-to-treat population in the event of non-inferiority. The trial was prospectively registered with ISRCTN Registry, ISRCTN12883981, and the trial is closed to new participants. FINDINGS ...