1. Non- or minimally displaced distal radius fractures in adult patients < 50 years of age: Three weeks of cast immobilisation versus one week of brace immobilisation: study protocol for a multicentre randomised controlled trial.
- Author
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van Delft, Eva A. K., van Bruggen, Suus G. J., Sosef, Nico L., Bloemers, Frank W., Schep, Niels W. L., and Vermeulen, Jefrey
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DISTAL radius fractures , *RANDOMIZED controlled trials , *RANGE of motion of joints , *TREATMENT of fractures , *MEDICAL protocols , *RADIAL bone , *SHOULDER - Abstract
Background: Currently, non- or minimally displaced distal radius fractures are treated by 3 to 5 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 1 week of immobilisation might be safe; however, no level 1 evidence is available. This trial aims to compare 1 week of brace immobilisation with 3 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 1 week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A two-armed single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18 and 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 1 week of brace immobilisation, and the control group with 3 weeks of cast immobilisation. Primary outcome is the patient-reported outcome measured by the Patient-Related Wrist Evaluation score (PRWE) at 6 months. Secondary outcomes are patient-reported outcome measured by the Quick Disabilities of the Arm, Shoulder and Hand score at 6 weeks and 6 months, PRWE at 6 weeks, range of motion, patient-reported pain score measured by VAS score, radiological outcome (dorsal/volar tilt, radial height, ulnar variance, presence of intra-articular step off), 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 1 evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients. Trial registration: ABR 81638 | NL81638.029.22 | www.toetsingonline.nl. 18th of October 2023 [ABSTRACT FROM AUTHOR]
- Published
- 2024
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