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

NCT ID: NCT03240471

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-07-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One week of plaster cast

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

Group Type: EXPERIMENTAL

One week of plaster cast

Intervention Type: PROCEDURE

One week of plaster cast as treatment for a non-reduced distal radius fracture.

Control; four-five weeks of plaster cast

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

Group Type: OTHER

Four-Five weeks of plaster cast

Intervention Type: PROCEDURE

Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

Interventions

One week of plaster cast

One week of plaster cast as treatment for a non-reduced distal radius fracture.

Intervention Type: PROCEDURE

Four-Five weeks of plaster cast

Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JP Frolke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Rijnstate hospital

Arnhem, , Netherlands

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Radboudumc

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

NL 59217.091.17

Identifier Type: -

Identifier Source: org_study_id