Clinical trial NCT06235957: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures
Official title: Non- or Minimally Displaced Distal Radius Fractures in Adult Patients <50 Years of Age Treated Non-operatively: Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation a Multicenter Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Fractures, Bone
Keywords: Distal radial fractures
non-operative treatment
immobilisation period
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital
name: Amsterdam UMC
First posted: 2024-02-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Background: Currently, non- or minimally displaced distal radius fractures are treated by three to five weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that one week of immobilisation might be safe, however, no level one evidence is available. This trial aims to compare one week of brace immobilisation with three weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.

Methods: The aim of this trial is to evaluate the non-inferiority of one week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18-50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with one week of brace immobilisation, and the control group with three weeks of cast immobilisation. Primary outcome is the Patient-Related Wrist Evaluation-score at six months. Secondary outcomes are: Quick Disabilities of the Arm, Shoulder and Hand-score at six weeks and six months, PRWE at six weeks, range of motion, pain, radiological outcome, complications and cost effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.

Discussion: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level one evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.

Eligibility criteria: Inclusion Criteria:

1. 18-50 years (to eliminate osteoporosis);
2. Primary non- or minimally displaced DRF;
3. Independent for activities of daily living.

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Related Wrist Evaluation
timeFrame: 6 months
Secondary outcomes:
measure: Patient Related Wrist Evaluation
timeFrame: 6 weeks
measure: Quick Disabilities of the Arm, Shoulder and Hand
timeFrame: 6 weeks, 6 months
measure: Range of motion
timeFrame: 6 weeks, 6 months
measure: Pain/Visual analogue scale score
timeFrame: at emergency department (day 0-1), one week, 6 weeks, 6 months
measure: Radiological outcome
timeFrame: 6 weeks, 6 months
measure: Complications
timeFrame: 6 weeks, 6 months
measure: Cost-effectiveness
timeFrame: 6 weeks, 6 months
measure: Cost-effectiveness
timeFrame: 6 weeks, 6 months
measure: Cost-effectiveness
timeFrame: 6 weeks, 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam Umc
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Amsterdam UMC
name: Frank W Bloemers, Prof
role: STUDY_CHAIR
References: