The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults

Britt Barvelink*, Max Reijman, Niels W.L. Schep, Vanessa Brown, Gerald A. Kraan, Taco Gosens, Suzanne Polinder, Erwin Ista, Jan A.N. Verhaar, Joost W. Colaris, the CAST study group, Merel van Loon

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)

Abstract

Background: There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated. Methods/design: This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n = 10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18 years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score ≥ 16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18 months. Discussion: The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery. Trial registration: Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311.

Original languageEnglish
Article number370
JournalBMC Musculoskeletal Disorders
Volume22
Issue number1
DOIs
Publication statusPublished - 20 Apr 2021

Bibliographical note

Funding Information:
The CAST study group consists of the following persons: Ninka Slebioda1, Mathieu M E Wijffels2, Marna G Bouwhuis3, Flip van Beek4, Daphne A van Rijssel5, Mark R de Vries6, Michiel Leijnen7, Peer van der Zwaal8, Merel van Loon9, Alexander P A Greeven10, Lenneke Scholtens11, Ruud LM Deijkers12, Marike C Kokke13, Milko M M Bruijninckx14Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands Department of Emergency Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands Department of Trauma Surgery, Franciscus Hospital, Rotterdam, The Netherlands Department of Emergency Medicine, Reinier de Graaf Gasthuis, Delft, The Netherlands Department of Trauma Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands Department of Trauma Surgery, Alrijne Hospital, Leiderdorp, The Netherlands Department of Orthopedic Surgery, Haaglanden Medical Center, The Hague, The Netherlands Department of Emergency Medicine, Haaglanden Medical Center, The Hague, The Netherlands Department of Trauma Surgery, Haga Hospital, The Hague, The Netherlands Department of Emergency Medicine, Haga Hospital, The Hague, The Netherlands Department of Orthopedic Surgery, Haga Hospital, The Hague, The Netherlands Department of Trauma Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands Department of Trauma Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands Study inclusion is ongoing and has started in May 2020.

Funding Information:
A grant is received from ZonMw (project number: 852002021), a Dutch organization for health research and care innovation. ZonMw was not involved in the study design, data collection, analysis and interpretation of data, nor in writing the manuscript.

Publisher Copyright:
© 2021, The Author(s).

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