Clinical trial NCT03240471: Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Distal radius fracture
Conservative treatment
Patient rated outcome (PRO)
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in patient-rated wrist evaluation (PRWE) questionnaire score
timeFrame: Week 6, month 3, month 6 and month 12
Secondary outcomes:
measure: Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score
timeFrame: Week 6, month 3, month 6 and month 12
measure: Change in Short-Form 36 questionnaire score
timeFrame: Week 6, month 3, month 6 and month 12
measure: Complications
timeFrame: Duration of study (12 months)
measure: Pain after DRF
timeFrame: Baseline, week 6, month 3, month 6, month 12
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: JP Frolke, Dr.
role: PRINCIPAL_INVESTIGATOR
References: