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

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 .

Keywords: Bone; Cast; Cost-effectiveness; Distal radius fracture; Fracture; Fracture displacement; Splint.

Fig. 1

Plaster splint

Fig. 2

Circumferential cast

Fig. 3

CAST study follow-up flowchart. ^*Type of treatment depends on randomization status of the hospital. ^μ Unacceptable alignment conform the Dutch guideline: > 15° of dorsal angulation, > 20° of volar angulation, < 15° of radial inclination, > 3 mm of radial shortening and > 2 mm intra-articular step-off or gap. ^∆ Cast immobilization, at least until the first control radiographs are taken. ^£ All measurements encountered in Table 1. ^¥ All questionnaires encountered in Table 1