Casting without prior reduction versus closed reduction for displaced wrist (distal radius) fractures in people 65 and 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
NA · Tampere University Hospital · NCT07042139
This trial will test whether simply putting a cast on displaced wrist fractures in people 65 and older works as well as doing a closed reduction before casting by measuring wrist pain and function at 12 months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 532 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital (other) |
| Locations | 10 sites (Viborg and 9 other locations) |
| Trial ID | NCT07042139 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls 532 patients aged 65 or older with low-energy displaced distal radius fractures and compares two approaches: immediate casting without attempting a closed reduction versus closed reduction under local anaesthetic followed by casting. Both groups receive a dorsal cast for five weeks, identical post-cast advice, and follow-up visits at 3 and 12 months, with the Patient-Rated Wrist Evaluation (PRWE) score at 12 months as the primary endpoint. No radiographs are taken during the casting period and an observational arm is offered for patients who decline randomization but consent to follow-up. The trial is run across multiple hospitals in Finland, Denmark, and Estonia with standardized treatment and outcome measurement protocols.
Who should consider this trial
Good fit: Independent-living adults aged 65 or older with a low-energy displaced distal radius fracture meeting the trial's angulation or shortening criteria and without exclusion conditions are ideal candidates.
Not a fit: Patients with volar angulation, partial articular (AO/OTA 23B) fractures, open or high-energy injuries, bilateral distal radius fractures, concomitant injuries affecting wrist use, or who cannot consent are unlikely to benefit from the no-reduction approach tested here.
Why it matters
Potential benefit: If successful, older patients with displaced wrist fractures could avoid a reduction procedure and still achieve similar long-term pain relief and wrist function, simplifying care and reducing discomfort.
How similar studies have performed: Previous trials and observational studies in older adults have produced mixed but sometimes favorable results for non-reduction casting, so this larger randomized trial aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Viborg and 9 other locations
- Viborg regional Hospital — Viborg, Denmark (RECRUITING)
- Tartu University Hospital — Tartu, Estonia (RECRUITING)
- Tampere University Hospital — Tampere, Pirkanmaa, Finland (RECRUITING)
- Helsinki University Hospital — Helsinki, Uusimaa, Finland (RECRUITING)
- Kanta-Häme Central Hospital — Hämeenlinna, Finland (RECRUITING)
- Kuopio University Hospital — Kuopio, Finland (RECRUITING)
- Oulu University Hospital — Oulu, Finland (RECRUITING)
- Pori Central Hospital — Pori, Finland (NOT_YET_RECRUITING)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Laura Kärnä, MD — Tampere University Hospital
- Study coordinator: Laura Kärnä, MD
- Email: laura.karna@pirha.fi
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Distal Radius Fracture, Casting, Closed Reduction, distal radius fracture, casting, closed reduction, nonoperative treatment, DISCLOSE trial