Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study)
BMJ Open , Volume 10 - Issue 9
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.
|Organisation||Department of Orthopaedics|
Cohen, A., Reijman, M, Kraan, G.A, Mathijssen, N.M.C, Koopmanschap, M.A, Verhaar, J.A.N, … Colaris, J.W. (2020). Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study). BMJ Open, 10(9). doi:10.1136/bmjopen-2020-036998