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

January 31, 2024 updated by: Spaarne Gasthuis

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

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 Contact

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081HV
        • Amsterdam UMC
        • Contact:
        • Sub-Investigator:
          • Eva AK van Delft, MD
      • Haarlem, Noord-Holland, Netherlands, 2035RC
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3079DZ

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

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Three weeks of cast immobilisation
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
Other: Group B
One week of brace immobilisation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Related Wrist Evaluation
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Related Wrist Evaluation
Time Frame: 6 weeks
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
Quick Disabilities of the Arm, Shoulder and Hand
Time Frame: 6 weeks, 6 months
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
Range of motion
Time Frame: 6 weeks, 6 months
Range of motion measured by goniometer
6 weeks, 6 months
Pain/Visual analogue scale score
Time Frame: at emergency department (day 0-1), one week, 6 weeks, 6 months
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
Radiological outcome
Time Frame: 6 weeks, 6 months
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
Complications
Time Frame: 6 weeks, 6 months
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
Cost-effectiveness
Time Frame: 6 weeks, 6 months
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
Cost-effectiveness
Time Frame: 6 weeks, 6 months
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
Cost-effectiveness
Time Frame: 6 weeks, 6 months
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

Collaborators and Investigators

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

Sponsor

Spaarne Gasthuis

Collaborators

Maasstad Hospital
Amsterdam UMC

Investigators

  • Study Chair: Frank W Bloemers, Prof, Amsterdam UMC

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABR 81638 | NL81638.029.22

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

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.

Subscribe