STRAP ACL

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 clinical 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).

318 patients (159 in each arm).

1. To compare the clinical effectiveness of the use of ACL synthetic tape augmentation during ACLR versus not using a synthetic tape augmentation based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT) 18 months post-randomisation.
2. To compare the cost-effectiveness of the use of a synthetic tape augmentation during ACLR versus not using a synthetic tape augment during ACLR from an NHS and personal social services (PSS) perspective.

1^st May 2026 - 31^st October 2029.