Britt Barvelink1, Max Reijman2, Niels W L Schep3, Vanessa Brown4, Gerald A Kraan5, Taco Gosens6, Suzanne Polinder7, Erwin Ista8, Jan A N Verhaar2, Joost W Colaris2. 1. Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands. b.barvelink@erasmusmc.nl. 2. Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000, Rotterdam, CA, The Netherlands. 3. Department of Trauma Surgery, Maasstad Hospital, Rotterdam, The Netherlands. 4. Department of Emergency Medicine, Franciscus Hospital, Rotterdam, The Netherlands. 5. Department of Orthopedic Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands. 6. Department of Orthopedic Surgery, Elisabeth-Tweesteden Hospital, Tilburg, The Netherlands. 7. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. 8. Department of Internal Medicine - Nursing Science, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
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 .
RCT Entities:
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 traumapatients (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 .
Authors: A Bentohami; J Bosma; G J M Akkersdijk; B van Dijkman; J C Goslings; N W L Schep Journal: Eur J Trauma Emerg Surg Date: 2014-03-27 Impact factor: 3.693
Authors: Young Hoon Jo; Bong Gun Lee; Joo Hak Kim; Chang Hun Lee; Sung Jae Kim; Wan Sun Choi; Ja Wook Koo; Kwang Hyun Lee Journal: J Korean Med Sci Date: 2017-07 Impact factor: 2.153
Authors: A C Berger; B Barvelink; M Reijman; T Gosens; G A Kraan; M R De Vries; M H J Verhofstad; K W W Lansink; P F W Hannemann; J W Colaris Journal: J Orthop Surg Res Date: 2021-12-20 Impact factor: 2.359