Distal Radius Fracture
Conditions
Keywords
Distal radius fracture, Conservative treatment, Patient rated outcome (PRO)
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.
Interventions
PROCEDUREOne week of plaster cast
One week of plaster cast as treatment for a non-reduced distal radius fracture.
PROCEDUREFour-Five weeks of plaster cast
Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-rated wrist evaluation (PRWE) questionnaire score | Week 6, month 3, month 6 and month 12 | Patient rated wrist evaluation score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in disability of the Arm, Shoulder and Hand (DASH) questionnaire score | Week 6, month 3, month 6 and month 12 | In addition to the PRWE questionnaire. |
| Change in Short-Form 36 questionnaire score | Week 6, month 3, month 6 and month 12 | In addition to the PRWE questionnaire. |
| Complications | Duration of study (12 months) | The number of participants who experienced treatment related complications scored with a checklist. |
| Pain after DRF | 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. |
Countries
Netherlands
Outcome results
None listed