DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.
| Autor: | Räisänen MP; Department of Hand and Microsurgery, Tampere University Hospital, Tampere, Finland., Karjalainen T; Department of Hand Surgery and Orthopaedics, Central Hospital of Central Finland, Jyväskylä, Finland., Göransson H; Department of Hand and Microsurgery, Tampere University Hospital, Tampere, Finland., Reito A; Department of Hand Surgery and Orthopaedics, Central Hospital of Central Finland, Jyväskylä, Finland., Kautiainen H; Medcare Ltd, Äänekoski, Finland., Malmivaara A; Centre for Health and Social Economics, National Institute for Health and Welfare, Helsinki, Finland., Leppänen OV; Department of Hand and Microsurgery, Tampere University Hospital, Tampere, Finland. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | BMJ open [BMJ Open] 2018 Mar 28; Vol. 8 (3), pp. e019054. Date of Electronic Publication: 2018 Mar 28. |
| DOI: | 10.1136/bmjopen-2017-019054 |
| Abstrakt: | Introduction: Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. Methods and Analysis: We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. Ethics and Dissemination: The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals. Trial Registration Number: NCT03192020; Pre-results. Competing Interests: Competing interests: MPR, shoulder arthroscopy course paid for by Arthrex and nerve repair course paid for by Axone. TK, cadaver course paid for by Articular Finland and lecture fee from Summed. (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|