RecruitingNot ApplicableNCT07042139

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


Sponsor

Tampere University Hospital

Enrollment

532 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Casting, a procedure called Closed Reduction, and others for people with casting, closed reduction, and other related conditions. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENo reduction

No reduction

PROCEDUREClosed Reduction

Closed reduction

OTHERCasting

Dorsal cast


Locations(10)

Viborg regional Hospital

Viborg, Denmark

Tartu University Hospital

Tartu, Estonia

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Pori Central Hospital

Pori, Finland

Turku University Hospital

Turku, Finland

Karolinska University Hospital

Stockholm, Sweden

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NCT07042139


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