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

Study acronym: DISCLOSE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 9 to 10v4
  2. Study sites: 8 to 9v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2025 to Aug 1, 2025
    • Site details revised at 8 of 8 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07042139
Lead Sponsor Tampere University Hospital
Collaborators: Kuopio University Hospital, Viborg Regional Hospital, Karolinska University Hospital, Helsinki University Central Hospital, Tartu University Hospital, Pori Central Hospital, Oulu University Hospital
Conditions
(from sponsor)		 Distal Radius Fracture, Casting, Closed Reduction
Related terms Wrist Fractures
Enrollment 532 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov