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

Radboud University Medical Center

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Procedure: Four-Five weeks of plaster cast; Procedure: One week of plaster cast

Study type: Interventional

Funder types: Other

Identifiers

NCT03240471

NL 59217.091.17

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years
• Isolated acute distal radius fracture
• Closed reduction is not performed
• Non-operative treatment with cast immobilisation
• Understanding of Dutch language

Exclusion criteria

• Under the age of 18 or older than 75 years
• Multiple injured patient
• Reduction is indicated/performed
• Operative treatment
• Not understanding of Dutch language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

One week of plaster cast

Experimental group

Description:

One week of plaster cast after a non-reduced distal radius fracture.

Treatment:

Procedure: One week of plaster cast

Control; four-five weeks of plaster cast

Other group

Description:

Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.

Treatment:

Procedure: Four-Five weeks of plaster cast