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Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial

Harrison, Samantha; Ogollah, Reuben; Hollingworth, William; Mills, Nicola; Karantana, Alexia; Blazeby, Jane; Montgomery, Alan; Shafayat, Aisha; Jarrett, Hugh; Davis, Tim

Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial Thumbnail


Authors

REUBEN OGOLLAH REUBEN.OGOLLAH@NOTTINGHAM.AC.UK
Associate Professor of Medical Statistics and Clinical Trials

William Hollingworth

Nicola Mills

ALEXIA KARANTANA ALEXIA.KARANTANA@NOTTINGHAM.AC.UK
Clinical Associate Professor in Hand Surgery

Jane Blazeby

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit

AISHA SHAFAYAT Aisha.Shafayat@nottingham.ac.uk
Research Facilitation Manager

HUGH JARRETT Hugh.Jarrett@nottingham.ac.uk
Senior Trial Manager

Tim Davis



Abstract

Background: Dupuytren’s contractures (DC) are fibrous cords under the skin of the hand that cause one or more fingers to curl gradually and irreversibly towards the palm. These contractures are usually painless but can cause a loss of hand function. Two treatments for Dupuytren’s contractures are widely used within the National Health Service (NHS) in the UK: removal of the contractures via surgery (limited fasciectomy) and division of the contractures via a needle inserted through the skin (needle fasciotomy). This study aims to establish the clinical and cost-effectiveness of needle fasciotomy (NF) versus limited fasciectomy (LF) for the treatment of DC in the NHS, in terms of patient-reported hand function and resource utilisation. Methods/design: Hand-2 is a national multi-centre, two-arm, parallel-group randomised, non-inferiority trial. Patients will be eligible to join the trial if they are aged 18 years or older, have at least one previously untreated finger with a well-defined Dupuytren’s contracture of 30° or greater that causes functional problems and is suitable for treatment with either LF or NF. Patients with a contracture of the distal interphalangeal joint only are ineligible. Eligible consenting patients will be randomised 1:1 to receive either NF or LF and will be followed up for 24 months post-treatment. A QuinteT Recruitment Intervention will be used to optimise recruitment. The primary outcome measure is the participant-reported assessment of hand function, assessed by the Hand Health Profile of the Patient Evaluation Measure (PEM) questionnaire at 12 months post-treatment. Secondary outcomes include other patient-reported measures, loss of finger movement, and cost-effectiveness, reported over the 24-month post-treatment. Embedded qualitative research will explore patient experiences and acceptability of treatment at 2 years post-surgery. Discussion: This study will determine whether treatment with needle fasciotomy is non-inferior to limited fasciectomy in terms of patient-reported hand function at 12 months post-treatment. Trial registration: International Standard Registered Clinical/soCial sTudy ISRCTN12525655. Registered on 18th September 2020.

Citation

Harrison, S., Ogollah, R., Hollingworth, W., Mills, N., Karantana, A., Blazeby, J., …Davis, T. (2024). Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial. Trials, 25(1), Article 398. https://doi.org/10.1186/s13063-024-08003-1

Journal Article Type Article
Acceptance Date Feb 21, 2024
Online Publication Date Jun 19, 2024
Publication Date 2024
Deposit Date Jun 20, 2024
Publicly Available Date Jun 20, 2024
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 25
Issue 1
Article Number 398
DOI https://doi.org/10.1186/s13063-024-08003-1
Keywords Needle fasciotomy, Randomised control trial, Patient acceptability, Hand surgery, Limited fasciectomy, Dupuytren’s contractures
Public URL https://nottingham-repository.worktribe.com/output/36300494
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08003-1