Journal Article

Effect of no reduction versus closed reduction on distal radius fractures in adults aged 65 years and older: a protocol for the DISCLOSE randomised equivalence trial

Kärnä, Laura, Christensen, Robin, Launonen, Antti P, Ponkilainen, Ville, Senholt, Tina, Ryhänen, Jorma, Østergaard, Helle, Li, Yan, Kukkonen, Juha, Reito, Aleksi, Paasikallio, Katriina, Brorson, Stig, Tootsi, Kaspar, Heikkinen, Juuso, Mattila, Ville M

2025

Overview

IntroductionDistal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.Methods and analysisThis is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.Ethics and disseminationEthical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.Protocol version6 July 2025, v1.0.Trial registration numberNCT07042139.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Aged / Aged, 80 and over / Casts, Surgical / Clinical outcomes / Clinical trials / Closed Fracture Reduction - methods / Closed reduction / Consent / Emergency medical care / Equivalence Trials as Topic / Evidence Based Practice / Female / Fractures, Closed / Frailty / Hand & wrist / Humans / Male / Multicenter Studies as Topic / Osteoporosis / Pain / Patient satisfaction / Protocol / Quality of life / Questionnaires / Randomized Controlled Trial / Trauma / Treatment Outcome / Wrist Fractures - therapy