No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
A Randomized Controlled Trial Comparing No Reduction to Closed Reduction for Distal Radius Fractures in Patients 65 Years and Older (DISCLOSE Trial): A Study Protocol
Tampere University Hospital
532 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
DISCLOSE trial is a randomized controlled trial including 532 participants with low-energy distal radius fractures. The primary objective is to evaluate whether casting without prior closed reduction is equivalent to casting following closed reduction with respect to wrist-related pain and disability, as measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months, in patients aged 65 years or older with a displaced distal radius fracture. * Primary endpoint will be PRWE at 12 months * Follow-up visits are scheduled at 3 and 12 months. 5-year follow-up will be considered as an exploratory endpoint
Eligibility
Inclusion Criteria5
- Age 65 years or older
- Independent living patients
- Displaced distal radius fracture (AO/OTA 23A/23C) with 15-40 degree dorsal angulation, and/or of shortening of the radius for more than 2 mm.
- Associated ulnar styloid fracture is permitted
- Low energy injury, (fall from \<1 m)
Exclusion Criteria9
- Patient unable to provide consent
- Patients who are actively working in a paid position
- Volar angulation, partial articular fractures (AO/OTA 23B)
- Concomitant fracture of the ulna proximal to the base of the styloid process
- Associated fracture or dislocation in any other body part that would affect the use of the injured distal radius
- Distal radius fractures in both arms
- Open injury, Gustilo 2 or higher
- No bony contact between the main fragments
- High energy injuries
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Interventions
No reduction
Closed reduction
Dorsal cast
Locations(10)
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NCT07042139