Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures (DRPIPIII)

Spaarne Gasthuis

Status: Not yet enrolling

Conditions: Distal Radius Fractures; Fractures, Bone

Treatments: Other: Cast 3 weeks; Other: Brace 1 week

Study type: Interventional

Funder types: Other

Identifiers

NCT06235957

ABR 81638 | NL81638.029.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Group A

Other group

Description:

Three weeks of cast immobilisation

Treatment:

Other: Cast 3 weeks

Group B

Other group

Description:

One week of brace immobilisation

Treatment:

Other: Brace 1 week