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

January 19, 2021 updated by: Radboud University Medical Center

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Nijmegen, Netherlands
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One week of plaster cast
One week of plaster cast after a non-reduced distal radius fracture.
One week of plaster cast as treatment for a non-reduced distal radius fracture.
Other: Control; four-five weeks of plaster cast
Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-rated wrist evaluation (PRWE) questionnaire score
Time Frame: Week 6, month 3, month 6 and month 12
Patient rated wrist evaluation score
Week 6, month 3, month 6 and month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
Time Frame: Week 6, month 3, month 6 and month 12
In addition to the PRWE questionnaire.
Week 6, month 3, month 6 and month 12
Change in Short-Form 36 questionnaire score
Time Frame: Week 6, month 3, month 6 and month 12
In addition to the PRWE questionnaire.
Week 6, month 3, month 6 and month 12
Complications
Time Frame: Duration of study (12 months)
The number of participants who experienced treatment related complications scored with a checklist.
Duration of study (12 months)
Pain after DRF
Time Frame: Baseline, week 6, month 3, month 6, month 12
Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable".
Baseline, week 6, month 3, month 6, month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JP Frolke, Dr., Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

February 14, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

August 2, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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