Anterior Cruciate Ligament (ACL) injuries Surgery
Conditions
Interventions
Once consent is given, patients will be randomised into two groups using an online tool:
1. ACL reconstruction with synthetic tape augmentation
2. ACL reconstruction without synthetic tape augmentatio
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. People (aged >=16 years) with an ACL rupture (diagnosed clinically, with MRI confirmation of injury to ACL) requiring ACLR 2. Provision of written informed consent 3. Able to access and willing to complete electronic questionnaires 4. Understands written English, or with support from family or friends
Exclusion criteria
Exclusion criteria: 1. Revision ACL reconstruction 2. Multi-ligament injury requiring surgery to another major knee ligament such as concomitant posterior cruciate or collateral ligament surgery 3. Knee injury requiring cartilage repair surgery, except simple debridement, or concurrent patellar instability surgery 4. Previous surgery on the same knee except minor arthroscopic procedures (in the opinion of the treating clinician): limited to arthroscopy alone, removal of loose bodies and/or partial meniscectomy 5. Unable to adhere to trial protocols or completion of questionnaires (the need to offer translations will be kept under review by the trial team) 6. Previous randomisation in the present trial (i.e. other knee)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Function measured using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT) at Baseline, 3-, 6-, 12- and 18-months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Health Utility measured using EQ5D-5L at Baseline, 3-, 6-, 12- and 18-months post-randomisation;Health Resource Use measured using Health Economic Questionnaire at Baseline, 3-, 6-, 12- and 18-months post-randomisation;Pain measured using Numeric Rating Scale at Baseline, 3-, 6-, 12- and 18-months post-randomisation;ACL Function measured using KOOS ACL (Knee Injury and Osteoarthritis Outcome Score) at Baseline and 18-months post-randomisation;ACL Clinical Failure measured using Pivot Shift Test at Baseline and 18-months post-randomisation;ACL Re-Rupture measured using Site-reported form and MRI at Baseline and ad-hoc throughout trial if participant identifies a re-rupture – confirmed via MRI;Return to Sport measured using Questionnaire at 6-, 12- and 18-months post-randomisation;Level of Sporting Participation measured using Marx Activity Rating Scale at Baseline, 3-, 6-, 12- and 18-months post-randomisation;Adverse Events and complications measured using Questionnaires and site-reported at Baseline, 3-, 6-, 12- and 18-months post-randomisation;Treatment Satisfaction measured using Questionnaire at 3-, 6-, 12- and 18-months post-randomisation;Global rating of change measured using Questionnaire at 3-, 6-, 12- and 18-months post-randomisation | — |
Countries
United Kingdom
Contacts
Public ContactKerry Raynes
Outcome results
None listed