Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study)
Introduction Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a cli...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036998.full |
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| author | Max Reijman Jan A N Verhaar Abigael Cohen Gerald A Kraan Nina M C Mathijssen Marc A Koopmanschap Sander Mol Joost W Colaris |
| author_facet | Max Reijman Jan A N Verhaar Abigael Cohen Gerald A Kraan Nina M C Mathijssen Marc A Koopmanschap Sander Mol Joost W Colaris |
| author_sort | Max Reijman |
| collection | DOAJ |
| description | Introduction Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a clinically suspected scaphoid fracture and normal initial radiographs is immobilisation with below-elbow cast for 2 weeks. However, most of these patients are treated unnecessarily because eventually less than 10% of them are diagnosed with an occult scaphoid fracture. To reduce overtreatment and costs as a result of unnecessary cast treatment in patients with a clinically suspected scaphoid fracture and normal initial radiographs, we designed a study to compare below-elbow cast treatment with supportive bandage treatment. We hypothesise that the functional outcome after 3 months is not inferior in patients treated with supportive bandage compared to patients treated with below-elbow cast, but with lower costs in the supportive bandage group.Methods and analysis The SUSPECT study is an open-labelled multicentre randomised controlled trial with non-inferiority design. A total of 180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs are randomised between two groups: 3 days of supportive bandage or 2 weeks of below-elbow cast. We aim to evaluate the functional outcome and cost-effectiveness of both treatments. The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score. Secondary outcomes include functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity.Ethics and dissemination The Medical Ethics Committee of the Erasmus MC Medical Centre, Rotterdam, approved the study protocol (MEC-2017-504). We plan to present the results after completion of the study at (inter)national conferences and publish in general peer-reviewed journals.Trial registration number NL6976. |
| format | Article |
| id | doaj-art-8921e558483c4cae8dec1b116dcd8328 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8921e558483c4cae8dec1b116dcd83282025-01-08T15:30:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-036998Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study)Max Reijman0Jan A N Verhaar1Abigael Cohen2Gerald A Kraan3Nina M C Mathijssen4Marc A Koopmanschap5Sander Mol6Joost W Colaris7Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The NetherlandsDepartment of Orthopaedics and Sports Medicine, Erasmus Medical Center, Rotterdam, The NetherlandsDepartment of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The NetherlandsDepartment of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, The NetherlandsDepartment of orthopaedic surgery, Reinier Haga Orthopedic Center, Zoetermeer, The NetherlandsHealth Economics and HTA, Erasmus University Rotterdam, Rotterdam, The NetherlandsDepartment of Emergency Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The NetherlandsDepartment of Orthopaedics and Sports Medicine, Erasmus MC, Rotterdam, NetherlandsIntroduction Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a clinically suspected scaphoid fracture and normal initial radiographs is immobilisation with below-elbow cast for 2 weeks. However, most of these patients are treated unnecessarily because eventually less than 10% of them are diagnosed with an occult scaphoid fracture. To reduce overtreatment and costs as a result of unnecessary cast treatment in patients with a clinically suspected scaphoid fracture and normal initial radiographs, we designed a study to compare below-elbow cast treatment with supportive bandage treatment. We hypothesise that the functional outcome after 3 months is not inferior in patients treated with supportive bandage compared to patients treated with below-elbow cast, but with lower costs in the supportive bandage group.Methods and analysis The SUSPECT study is an open-labelled multicentre randomised controlled trial with non-inferiority design. A total of 180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs are randomised between two groups: 3 days of supportive bandage or 2 weeks of below-elbow cast. We aim to evaluate the functional outcome and cost-effectiveness of both treatments. The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score. Secondary outcomes include functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity.Ethics and dissemination The Medical Ethics Committee of the Erasmus MC Medical Centre, Rotterdam, approved the study protocol (MEC-2017-504). We plan to present the results after completion of the study at (inter)national conferences and publish in general peer-reviewed journals.Trial registration number NL6976.https://bmjopen.bmj.com/content/10/9/e036998.full |
| spellingShingle | Max Reijman Jan A N Verhaar Abigael Cohen Gerald A Kraan Nina M C Mathijssen Marc A Koopmanschap Sander Mol Joost W Colaris Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) BMJ Open |
| title | Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) |
| title_full | Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) |
| title_fullStr | Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) |
| title_full_unstemmed | Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) |
| title_short | Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? ‘Study protocol of a multicenter randomized controlled trial’ (SUSPECT study) |
| title_sort | clinically suspected scaphoid fracture treatment with supportive bandage or cast study protocol of a multicenter randomized controlled trial suspect study |
| url | https://bmjopen.bmj.com/content/10/9/e036998.full |
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