Study name: HAND-2 Status: Recruiting patients
Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers: a randomised non-inferiority trial.
Contact:
HAND2@nottingham.ac.uk
Lead Investigator:
Tim Davis
What is the study about?
Adults referred from primary to secondary care with a Dupuytren’s contracture (DC) of the hand are usually treated with either a needle fasciotomy (NF) or a limited fasciectomy (LF). In the Hand-2 trial, participants will be randomised to one treatment or the other and will complete questionnaires for two years post-treatment concerning their hand health and function.
The main aim is to determine whether, in adults with symptomatic DC of the hand, treatment with NF is non-inferior to LF in terms of hand function (assessed with the Hand Health Profile of the PEM) at 12 months post-intervention.
Who can take part in the study?
Adults with a Dupuytren’s contracture of the hand.
What is being tested in the study?
Needle fasciotomy - a needle is used to divide the contracture, releasing the tightness to allow finger/s to straighten. No cut is made in the skin, and no stitches are needed.
What is this being compared to?
Llimited fasciectomy - a surgeon will cut the skin in the hand and then remove the contracture and straighten the finger. The patient will have stitches to close the wound, which may need to be removed.
What are we trying to find out?
The clinical and cost-effectiveness of NF in terms of patient reported hand function and symptoms and resource utilisation
How many patients do we need?
406
Funder:
NIHR
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