Strap ACL V1.0
Research type
Research Study
Full title
Synthetic Tape Reconstruction Augmentation in Primary ACL injuries: a randomised trial
IRAS ID
358746
Contact name
Hema Mistry
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
This is a multi-centre, pragmatic, participant- and assessor-blinded, superiority RCT with 1:1 allocation and parallel health economic evaluation. The trial will include a six-month internal pilot to test detailed trial procedures, data collection and confirm the feasibility of recruitment and conduct. The participants and any assessors who assist patients in completing outcomes will be blinded to group allocation. Participants will be followed up to 18-months post-randomisation to assess patient-reported function, ACL graft failure, ACL re-rupture, return-to-sport, physical activity level, health-related quality of life (HRQoL), adverse events/post-operative complications and to collect resource use and cost data for an economic evaluation.
The trial design follows a pragmatic approach and reflects the realities of treatment delivery in the NHS. The design is sufficiently powered (90% power with 5% significance, standardised effect size of 0.41). Permission will be requested from the trial participants for long-term follow-up (up to 20 years).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0190
Date of REC Opinion
11 Jun 2026
REC opinion
Favourable Opinion