Preventing osteoarthritis after an ACL tear
The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis
This study is testing if a 6-month online education and exercise program can help young people who have had ACL surgery prevent osteoarthritis and improve their knee health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT06195423 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) for individuals aged 16-35 who have undergone anterior cruciate ligament reconstruction (ACLR) 9-36 months prior. Participants will be randomized to receive either the SOAR program or a minimal intervention control. The study will assess improvements in knee health, including pain, symptoms, function, and quality of life at 6, 12, and 24 months. Additionally, the trial will analyze the cost-effectiveness and implementation of the SOAR program.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-35 who are 9-36 months post-ACLR and currently live in British Columbia, Canada.
Not a fit: Patients with a previous diagnosis of knee osteoarthritis or those currently receiving knee care may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of developing early-onset osteoarthritis in young individuals after an ACL injury.
How similar studies have performed: Other studies have shown promise in using education and exercise interventions to improve outcomes in knee injuries, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently live in British Columbia, Canada * 16-35 years of age (inclusive) * 9-36-months past a first-time ACLR performed ≤12-months of first-time ACL tear * Currently not receiving knee care from a health or fitness provider and have no scheduled surgical procedures (any part of the body) that would interfere with exercise during the study. * Score below a KOOS4 PASS (\<79 points) * Have daily access to an email address and a computer with internet * Are willing to wear an activity tracker during the study Exclusion Criteria: * Inability to communicate in English * No medical attention (healthcare provider) time-loss (missed physical activity, sport or work ≥2 occasions) injury to the ACLR knee before the ACL tear * Previous physician diagnosis of index knee osteoarthritis * Inflammatory arthritis or other systemic condition * Lower limb injury, surgery, or intra-articular injection in the past 6-months * Current pregnancy * MRI contraindications (i.e., Weight over 400 lbs (MRI machine limit); Pacemaker or any other implanted medical device (i.e., wires, defibrillator, artificial heart valve, an electronic device like a drug infusion pump, electrical stimulator for nerves or bones, coil, catheter, or filter in any blood vessel, ear or eye implant, or stainless steel intrauterine device (IUD); Brain or ferromagnetic aneurysm clip; any other metallic prostheses or shrapnel, bullets, or other metal fragments; injury where a piece of metal lodged in the eye or orbit, or; surgery, medical procedure or tattoos (including tattooed eyeliner) in the last 6 weeks).
Where this trial is running
Vancouver, British Columbia and 1 other locations
- Arthritis Research Canada — Vancouver, British Columbia, Canada (Recruiting)
- Sea to Sky Orthopaedics — Whistler, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Jackie L Whittaker, BScPT, PhD — University of British Columbia
- Study coordinator: Jackie L Whittaker, BScPT, PhD
- Email: jackie.whittaker@ubc.ca
- Phone: 604-202-1362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.