Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study).

Autor:	Cohen A; Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands a.cohen.1@erasmusmc.nl., Reijman M; Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands., Kraan GA; Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands., Mathijssen NMC; Department of Orthopaedics, Reinier de Graaf Hospital, Delft, Zuid-Holland, The Netherlands., Koopmanschap MA; Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Zuid-Holland, The Netherlands., Verhaar JAN; Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands., Mol S; Department of Emergency Medicine, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands., Colaris JW; Department of Orthopaedics, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Sep 29; Vol. 10 (9), pp. e036998. Date of Electronic Publication: 2020 Sep 29.
DOI:	10.1136/bmjopen-2020-036998
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu