Abstract
BackgroundThe 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.MethodsThis 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.DiscussionThe 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 registrationNetherlands Trial Register NL9278. Registered on 17 February 2021
Highlights
The distal radius fracture (DRF) is a common fracture, with the majority of these fractures being stable
The secondary outcome scores are the Patient-Rated Wrist Evaluation score (PRWE), Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference, return to activity measuring with the productivity costs questionnaire, pain and the use of pain medication, Quality of Life (QOL) using the EuroQol-5 dimensions 5-level questionnaire (EQ-5D5L), Pain Catastrophizing Scale (PCS-4), patient satisfaction, complications using the complication checklist of McKay measured at 6 weeks and 3, 6, and 12 months post-injury
A limitation of this study is the variability in clinical judgment when to reduce a DRF and thereby the chance of bias due to the surgeon’s decision who expects a high chance of secondary displacement
Summary
The distal radius fracture (DRF) is a common fracture, with the majority of these fractures being stable. There is a large variation in treatment advisements for non-reduced DRF. Shorter immobilization periods for non-reduced distal radius fractures may prove to be cost-effective. 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. The distal radius fracture (DRF) is a common fracture. Recent literature mainly focused on treatment options for unstable distal radius fractures, for which several treatment modalities have been advocated [4, 5]. There are only a few studies that have investigated the duration of immobilization for non-operatively treated, stable DRFs [6]. The authors concluded that an immobilization period of 3 weeks or less is effective compared to the longer immobilization period and might be associated with better functional outcome [6]
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