Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures

NCT ID: NCT06235957

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-01

Brief Summary

Three weeks of cast immobilisation versus one week of brace immobilisation in non- or minimally displaced distal radius fractures in adult patients <50 years of age treated non-operatively.

Detailed Description

Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.

Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.

Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.

Conditions

Distal Radius Fractures; Fractures, Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Three weeks of cast immobilisation

Group Type: OTHER

Cast 3 weeks

Intervention Type: OTHER

patients will be treated either in a cast or a brace, patients in group A are treated by cast immobilization for 3 weeks

Group B

One week of brace immobilisation

Group Type: OTHER

Brace 1 week

Intervention Type: OTHER

patients will be treated either in a cast or a brace, patients in group B are treated in a brace for 1 week

Interventions

Cast 3 weeks

patients will be treated either in a cast or a brace, patients in group A are treated by cast immobilization for 3 weeks

Intervention Type: OTHER

Brace 1 week

patients will be treated either in a cast or a brace, patients in group B are treated in a brace for 1 week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 18-50 years (to eliminate osteoporosis);

2. Primary non- or minimally displaced DRF;

3. Independent for activities of daily living.

Exclusion Criteria

1. Fracture of the contralateral wrist;

2. Ipsilateral fractures, proximal of the DRF;

3. Pre-existent abnormalities or functional deficits of the fractured wrist;

4. Open fractures;

5. Polytrauma patients

6. Language disability to understand the Dutch patient information and questionnaires.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maasstad Hospital

OTHER

Sponsor Role: collaborator

Amsterdam UMC

OTHER

Sponsor Role: collaborator

Spaarne Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank W Bloemers, Prof

Role: STUDY_CHAIR

Amsterdam UMC

Locations

Amsterdam Umc

Amsterdam, North Holland, Netherlands

Spaarne Gasthuis

Haarlem, North Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Central Contacts

Eva van Delft, MD

Role: CONTACT

e.vandelft@amsterdamumc.nl

020 - 566 3111

Facility Contacts

Suus GJ van Bruggen, MD

Role: primary

s.vanbruggen@amsterdamumc.nl

020-5669111

Nico L Sosef, MD

Role: primary

nsosef@spaarnegasthuis.nl

023-22400000

Niels WL Schep, MD PhD

Role: primary

schepn@maasstadziekenhuis.nl

010 291 1911

Other Identifiers

ABR 81638 | NL81638.029.22

Identifier Type: -

Identifier Source: org_study_id