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

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

Conditions

• Distal Radius Fracture
• Casting
• Closed Reduction

Interventions

PROCEDURE

No reduction

No reduction

PROCEDURE

Closed Reduction

Closed reduction

OTHER

Casting

Dorsal cast

Sponsors & Collaborators

• Kuopio University Hospital

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Tartu University Hospital

  collaborator OTHER

• Pori Central Hospital

  collaborator UNKNOWN

• Oulu University Hospital

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Laura Kärnä, MD · Tampere University Hospital

• Ville Ponkilainen · Tampere University Hospital

• Antti Launonen · Tampere University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-01

Primary Completion

2029-07-01

Completion

2033-07-01

Countries

• Denmark
• Estonia
• Finland
• Sweden

Study Locations