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

NCT06235957 | Not Yet Recruiting

• 1 other identifier: ABR 81638 | NL81638.029.22
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Distal Radius Fractures; Fractures, Bone

Keywords

Distal radial fractures; non-operative treatment; immobilisation period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Patient Related Wrist Evaluation

  6 weeks

• Quick Disabilities of the Arm, Shoulder and Hand

  6 weeks, 6 months

• Range of motion

  6 weeks, 6 months

• Pain/Visual analogue scale score

  at emergency department (day 0-1), one week, 6 weeks, 6 months

• Radiological outcome

  6 weeks, 6 months

Study Arms (2)

Group A

OTHER

Three weeks of cast immobilisation

Other: Cast 3 weeks

Group B

OTHER

One week of brace immobilisation

Other: Brace 1 week

Interventions

Cast 3 weeks 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 A

Brace 1 week OTHER

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

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years (to eliminate osteoporosis);
• Primary non- or minimally displaced DRF;
• Independent for activities of daily living.

You may not qualify if:

• Fracture of the contralateral wrist;
• Ipsilateral fractures, proximal of the DRF;
• Pre-existent abnormalities or functional deficits of the fractured wrist;
• Open fractures;
• Polytrauma patients
• Language disability to understand the Dutch patient information and questionnaires.

Sponsors & Collaborators

• Spaarne Gasthuis: lead
• Maasstad Hospital: collaborator
• Amsterdam UMC: collaborator

Study Sites (3)

Amsterdam Umc

Amsterdam, North Holland, 1081HV, Netherlands

Location

Spaarne Gasthuis

Haarlem, North Holland, 2035RC, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079DZ, Netherlands

Location

MeSH Terms

Conditions

Wrist Fractures; Fractures, Bone

Interventions

POLR1G protein, human; Braces

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Frank W Bloemers, Prof

  Amsterdam UMC

  STUDY CHAIR

Central Study Contacts

Eva van Delft, MD

CONTACT

020 - 566 3111; e.vandelft@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded evaluation of the trial patients functional status, radiographs and range of motion will be performed by a research assistant by use of the PRWE and qDASH scores
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted as a single-blinded multicentre randomised clinical trial in three hospitals. In this study, three weeks of cast immobilisation is compared to one week of brace immobilisation.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: February 1, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)