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

NCT03240471 | Completed DMC

• 1 other identifier: NL 59217.091.17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture; Conservative treatment; Patient rated outcome (PRO)

Outcome Measures

Primary Outcomes (1)

• Change in patient-rated wrist evaluation (PRWE) questionnaire score

  Patient rated wrist evaluation score

  Week 6, month 3, month 6 and month 12

Secondary Outcomes (4)

• Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score

  Week 6, month 3, month 6 and month 12

• Change in Short-Form 36 questionnaire score

  Week 6, month 3, month 6 and month 12

• Complications

  Duration of study (12 months)

• Pain after DRF

  Baseline, week 6, month 3, month 6, month 12

Study Arms (2)

One week of plaster cast

EXPERIMENTAL

One week of plaster cast after a non-reduced distal radius fracture.

Procedure: One week of plaster cast

Control; four-five weeks of plaster cast

OTHER

Four-five weeks of plaster cast after a non-reduced distal radius fracture, usual care.

Procedure: Four-Five weeks of plaster cast

Interventions

One week of plaster cast PROCEDURE

One week of plaster cast as treatment for a non-reduced distal radius fracture.

One week of plaster cast

Four-Five weeks of plaster cast PROCEDURE

Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.

Control; four-five weeks of plaster cast

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18 or older than 75 years
• Multiple injured patient
• Reduction is indicated/performed
• Operative treatment
• Not understanding of Dutch language

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (3)

Rijnstate hospital

Arnhem, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• JP Frolke, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 7, 2017
• Study Start: October 1, 2017
• Primary Completion: February 14, 2020
• Study Completion: July 1, 2020
• Last Updated: January 20, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)