Anterior cruciate ligament injuries Musculoskeletal Diseases
Conditions
Interventions
The ACL STARR study is a randomised controlled trial. Participants will be allocated to either repair or reconstruction surgery at random using a computer. This will enable us to find out which treatm
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
14 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 14 years and above 2. Willing & able to provide informed consent and comply with study procedures 3. Proximal ACL tear pattern suitable for both repair or reconstruction 4. Willing to accept either study arm allocation
Exclusion criteria
Exclusion criteria: 1. History of major knee surgery: Have had previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to the index knee 2. Concomitant severe injury to the contra-lateral knee 3. High grade multi ligament injury: High grade injuries to other ligaments (i.e. medial collateral, lateral collateral, posterior cruciate) in the knee (Grade > 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS-4) questionnaire at baseline and 24 months post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. KOOS score is measured using KOOS 5 Questionnaire at 6, 12, and 24 months after randomisation 2. Resource use data is measured using Health Economics Questionnaire and EQ-5DL & -VAS Questionnaire at 6, 12, and 24 months after randomisation 3. Emotional functioning is measured using Emotional Functioning Questionnaire at baseline, 6, 12, and 24 months after randomisation 4. Surgeon confidence is measured using Surgery Case Report Form on the day of surgery 5. Post-operative pain score is measured using Pain NRS at 3 and 6 weeks after randomisation 6. Time to return to sport is measured using Modified Tegner Questionnaire and Tegner Questionnaire at baseline, 6, 12, and 24 months after randomisation 7. Patient satisfaction is measured using Patient Satisfaction Questionnaire at 12 and 24 months after randomisation 8. Intervention-related complications are measured using Health Economics Questionnaire and Case Report Form at 6, 12, and 24 months after randomisation 9. Objective evidence of graft/repair failure is measured using Case Report Form up to 24 months after randomisation | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactJennifer;Nick O'Callaghan;Beale
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Outcome results
None listed