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 redu...
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| Format: | Article |
| Language: | English |
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BMC
2021-04-01
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| Series: | BMC Musculoskeletal Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12891-021-04238-0 |
| _version_ | 1818383758956429312 |
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| author | 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 on behalf of the CAST study group |
| author_facet | 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 on behalf of the CAST study group |
| author_sort | Britt Barvelink |
| collection | DOAJ |
| description | 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 . |
| first_indexed | 2024-12-14T03:11:28Z |
| format | Article |
| id | doaj.art-dad4abe31eed41749ad5e3080b181ba9 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-14T03:11:28Z |
| publishDate | 2021-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-dad4abe31eed41749ad5e3080b181ba92022-12-21T23:19:15ZengBMCBMC Musculoskeletal Disorders1471-24742021-04-012211910.1186/s12891-021-04238-0The 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 adultsBritt Barvelink0Max Reijman1Niels W. L. Schep2Vanessa Brown3Gerald A. Kraan4Taco Gosens5Suzanne Polinder6Erwin Ista7Jan A. N. Verhaar8Joost W. Colaris9on behalf of the CAST study groupDepartment of Orthopedic Surgery, Erasmus MC, University Medical Center RotterdamDepartment of Orthopedic Surgery, Erasmus MC, University Medical Center RotterdamDepartment of Trauma Surgery, Maasstad HospitalDepartment of Emergency Medicine, Franciscus HospitalDepartment of Orthopedic Surgery, Reinier de Graaf GasthuisDepartment of Orthopedic Surgery, Elisabeth-Tweesteden HospitalDepartment of Public Health, Erasmus MC, University Medical Center RotterdamDepartment of Internal Medicine – Nursing Science, Erasmus MC, University Medical Center RotterdamDepartment of Orthopedic Surgery, Erasmus MC, University Medical Center RotterdamDepartment of Orthopedic Surgery, Erasmus MC, University Medical Center RotterdamAbstract 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 .https://doi.org/10.1186/s12891-021-04238-0FractureBoneDistal radius fractureCastSplintFracture displacement |
| spellingShingle | 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 on behalf of the CAST study group 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 BMC Musculoskeletal Disorders Fracture Bone Distal radius fracture Cast Splint Fracture displacement |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Fracture Bone Distal radius fracture Cast Splint Fracture displacement |
| url | https://doi.org/10.1186/s12891-021-04238-0 |
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