Flexor tendon repairs - FIRST Study
Research type
Research Study
Full title
Prospective randomised controlled trial comparing three splints for finger flexor tendon repairs (FIRST study).
IRAS ID
310986
Contact name
Emma Bamford
Contact email
Sponsor organisation
University Hospitals Derby & Burton NHS Foundation Trust
ISRCTN Number
ISRCTN10236011
Duration of Study in the UK
3 years, 4 months, 31 days
Research summary
After surgery, repaired flexor tendons must be protected with a splint to prevent newly repaired tendons rupturing, while allowing finger movement to prevent stiffness. Wearing splints prevents normal hand movement, restricts activities of daily living and affects return to work, however, poor splint adherence can lead to newly repaired tendons rupturing. Three custom-made splints are available on the NHS, each with a different harm benefit profile: ‘long’ (restricts wrist/fingers); ‘short’ (restricts hand); ‘mini’ (restricts fingers). However, we do not know which splint is best.
This study aims to investigate splint clinical and cost effectiveness, and mediators of effectiveness. Patients undergoing rehabilitation following the surgical repair of zone I/II flexor tendons will be invited to take part and will randomly be allocated to receive either a ‘long’, ‘short’ or ‘mini’ splint. Patients will be followed up at four timepoints over a year to assess pain and function during rehabilitation.
Compliance to splint prescriptions will be measured and interviews and surveys will also be conducted to understand determinants of adherence to the different splints, and to understand how adherence mediates pain and function. An economic evaluation within the trial will estimate the cost-effectiveness of each splint.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
22/SW/0074
Date of REC Opinion
26 May 2022
REC opinion
Favourable Opinion