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Cast OFF-2: 1 week of plaster cast immobilization for non-reduced distal radius fractures-a study protocol for an
Emily Boersma1, Erik van de Krol2, Tjarda Tromp2
1Department of Surgery, Radboud University Medical Center, Radboud Institute for Health Sciences, route 618, P.O. Box 9101, NL-6500, HB, Nijmegen, the Netherlands. emily.boersma@radboudumc.nl.
Background:
The distal radius fracture (DRF) is a common fracture, with the majority of these fractures being stable. Of all diagnosed fractures, 17% is a DRF, of which a large part is extra-articular and one-third is non-displaced. There is a large variation in treatment advisements for non-reduced DRF. Four to 5 weeks of immobilization is often the usual practice. Existing evidence shows that 1 week of immobilization is safe and does not lead to an increase in secondary displacement. Additionally, shorter immobilization periods may lead to less outpatient clinic visits and less home care for elderly people and may lead to earlier return to work and other social activities. Therefore, shorter immobilization periods for non-reduced distal radius fractures may also prove to be cost-effective. In this study, we aim to successfully implement 1 week of plaster cast immobilization for non-reduced distal radius fractures in twelve medical centers and to evaluate the functional outcome and cost-effectiveness.
Methods:
This study will be performed using a multicenter randomized stepped wedge design in 12 centers. We aim to include in the study 440 patients with an isolated non-reduced DRF between the age of 18 and 85 years old. The patients in the intervention group will be treated with plaster cast immobilization for 1 week. Acceptability of the study protocol, patient-reported outcomes, quality of life, complications, pain catastrophizing score, pain and patient satisfaction, and cost-effectiveness will be measured. The total follow-up will be 12 months.
Discussion:
The strength of this study is the combination of implementing 1 week of plaster cast immobilization for non-reduced DRF and the evaluation of functional outcome, acceptability of the study protocol, and cost-effectiveness in actual practice.
Trial Registration:
Netherlands Trial Register NL9278 . Registered on 17 February 2021.
