No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTampere University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- No reduction
- Closed Reduction
- Casting
Treatment groups
532 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tampere University Hospital
Lead sponsor
Kuopio University Hospital
Collaborator
Viborg Regional Hospital
Collaborator
Karolinska University Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Tartu University Hospital
Collaborator
Pori Central Hospital
Collaborator
Oulu University Hospital
Collaborator
Source ClinicalTrials.gov