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

Distal Radius Fracture Clinical Trial

— Cast-OFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240471
• Other study ID #: NL 59217.091.17
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• One week of plaster cast
One week of plaster cast as treatment for a non-reduced distal radius fracture.
• Four-Five weeks of plaster cast
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient-rated wrist evaluation (PRWE) questionnaire score	Patient rated wrist evaluation score	Week 6, month 3, month 6 and month 12
Secondary	Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score	In addition to the PRWE questionnaire.	Week 6, month 3, month 6 and month 12
Secondary	Change in Short-Form 36 questionnaire score	In addition to the PRWE questionnaire.	Week 6, month 3, month 6 and month 12
Secondary	Complications	The number of participants who experienced treatment related complications scored with a checklist.	Duration of study (12 months)
Secondary	Pain after DRF	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