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Recruiting NCT07042139

No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older

Trial Parameters

Condition Distal Radius Fracture
Sponsor Tampere University Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 532
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2025-08-01
Completion 2029-07-01
Interventions
No reductionClosed ReductionCasting

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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