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

Fractures, Bone Clinical Trial

— DRPIPIII  

Official title:

Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235957
• Other study ID #: ABR 81638 | NL81638.029.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: January 2024
• Source: Spaarne Gasthuis
• Contact: Eva van Delft, MD
• Phone: 020 - 566 3111
• Email: e.vandelft[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Netherlands	Amsterdam Umc	Amsterdam	Noord-Holland
Netherlands	Spaarne Gasthuis	Haarlem	Noord-Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Spaarne Gasthuis	Amsterdam UMC, Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Related Wrist Evaluation	The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.	6 months
Secondary	Patient Related Wrist Evaluation	The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six weeks The primary outcome measure is the PRWE (Patient Related Wrist Evaluation) score after six months. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.	6 weeks
Secondary	Quick Disabilities of the Arm, Shoulder and Hand	shortened version of the DASH Outcome Measure, using 11 items instead of 30 (scored 1-5) to measure pain and functional outcome. At least 10 of the 11 items must be completed to calculate a score. The scores will be transformed to a 0-100. A higher score indicates greater disability.	6 weeks, 6 months
Secondary	Range of motion	Range of motion measured by goniometer	6 weeks, 6 months
Secondary	Pain/Visual analogue scale score	Pain measured by VAS score VAS-score is a widely used method for pain assessments. Patients score their pain on a scale of 1-10. A higher score indicated a higher level of pain.	at emergency department (day 0-1), one week, 6 weeks, 6 months
Secondary	Radiological outcome	Analysis of X-rays, dorsal and volar tilt in degrees, radial height in millimetres and ulnar variance in millimetres will be calculated	6 weeks, 6 months
Secondary	Complications	Complications secondary displacement (radial shortening >3mm, dorsal tilt >10° or intra-articular step-off >2mm), delayed/non-union, re-interventions, complex regional pain syndrome (CRPS), tendon injuries (ruptures and tendinitis), nerve injuries (carpal tunnel syndrome and lesions), and distal radial ulnar joint disability.	6 weeks, 6 months
Secondary	Cost-effectiveness	Cost-effectiveness measured by iMCQ (Medical Consumption questionnaires) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months	6 weeks, 6 months
Secondary	Cost-effectiveness	Cost-effectiveness measured by iPCQ (Productivity Cost Questionnaire) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months	6 weeks, 6 months
Secondary	Cost-effectiveness	Cost-effectiveness measured by EuoQol 5D (Euroquol quality of life score) Only the applicable items are included in this study. To create baseline data patients will be asked to complete those questionnaires at the ED at the day of trauma (t = 0). Patients will also be asked to complete these questionnaires at 6 weeks and 6 months	6 weeks, 6 months