NCT03240471

Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization

Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization for Non-reduced Distal Radius Fractures: A Randomized Clinical Trial - A Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Distal radius fracture (DRF) is a common fracture of which the incidence appears to be increasing worldwide. On average, a total of 17% of all diagnosed fractures are DRF's. In the Dutch guideline for DRF the treatment advice for DRF, without reduction, is treatment with plaster cast or brace for one-three weeks. Despite the advice in the guideline and despite several studies from the 90's showing that plaster cast treatment of a stable DRF for one week is safe, the usual length of plaster cast treatment for stable DRF is four-six weeks. In addition, recent studies have also shown that a long period of immobilization can lead to more post traumatic pain by increasing disuse and kinesiophobia. This evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for DRF is unnecessary. The aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. In addition, this feasibility study will be used to define the sample size of the future RCT.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
PROCEDURE	One week of plaster cast	One week of plaster cast as treatment for a non-reduced distal radius fracture.
PROCEDURE	Four-Five weeks of plaster cast	Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-02-14
• Completion: 2020-07-01
• First posted: 2017-08-07
• Last updated: 2021-01-20

Locations

3 sites across 1 country: Netherlands