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Completed

NCT Number: NCT03240471

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate hospital, Arnhem, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

One week of plaster cast

Procedure

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

Four-Five weeks of plaster cast

Procedure

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

Primary outcomes

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

    Time frame: Week 6, month 3, month 6 and month 12

    Patient rated wrist evaluation score

Secondary outcomes

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

    Time frame: Week 6, month 3, month 6 and month 12

    In addition to the PRWE questionnaire.

  2. Change in Short-Form 36 questionnaire score

    Time frame: Week 6, month 3, month 6 and month 12

    In addition to the PRWE questionnaire.

  3. Complications

    Time frame: Duration of study (12 months)

    The number of participants who experienced treatment related complications scored with a checklist.

  4. Pain after DRF

    Time frame: Baseline, week 6, month 3, month 6, month 12

    Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable".

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization for Non-reduced Distal Radius Fractures: A Randomized Clinical Trial - A Feasibility Trial

Acronym: Cast-OFF

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2017
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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