Stopping OsteoARthritis After an ACL Tear

Condition(s) studied

Investigational drug(s) / intervention(s)

Stop OsteoARthritis (SOAR) program: The SOAR program is a 6-month, online-delivered (videoconferencing), PT-guided knee health program which consists of; 1. Knee Camp: Includes interactive education, and 1:1 physiotherapy knee exam and counseling session to co-identify home-based exercise-therapy and physical activity goals to address participants' unique functional limitations. Participants are given a wrist-worn activity monitor to wear 24hours/day. 2. Individualized Weekly Home-based Exercise-Therapy and Physical Activity Program: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises and physical activity are tracked with an online form and the activity monitor. Participants can also attend an optional weekly group class. 3. Weekly PT-guided Exercise-Therapy and Physical Activity Counselling: Each week, participants attend a 1:1 physiotherapist counseling session to modify exercise-therapy and physical activity goals.

Living Well after ACLR program: Participants in the minimal intervention CONTROL group will receive access to a 30-minute educational video (knee anatomy, ACLR information, general exercise, physical activity, and goal-setting principles), a best practice workbook, one video-recorded virtual session with a physiotherapist (naïve to SOAR) who will explain the booklet and answer questions but not volunteer information beyond the video or booklet and the same wrist-worn activity tracker as the experimental group.

Study summary

By 2040, 25% of Canadians will have osteoarthritis, a disabling joint condition. Most people think osteoarthritis only affects older adults, but 50% of the 700,000 Canadian youth who hurt their knee playing sports annually will develop osteoarthritis by 40 years of age. These young people with old knees face knee pain and disability for much of their adult lives, interfering with parenting, work, and recreation. Yet, most do not know about osteoarthritis or how to reduce their risk.

In this clinical trial, people who have torn the Anterior Cruciate ligament in their knee and had reconstruction surgery 9-36 months previously will be randomized to receive either a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) or a minimal intervention control program. Researchers will test if those who received the SOAR program have larger gains in knee health, including pain, symptoms, function, and quality of life at 6, 12, and 24 months. Researchers will also use MRIs (baseline and 24 months) to assess how the SOAR program influences knee cartilage degeneration and its cost-effectiveness.

Eligibility

Primary outcome measure(s)

• Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants) — Change from baseline KOOS score at 6 months (ACL tear participants)
  Patient partners identify pain, function and quality of life, which can be impaired up to 10-years post-ACLR, as priority outcomes. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a valid and reliable patient-reported outcome measure (PROM) with sub-scales for knee pain (9-items), other symptoms (7-items), function in daily living (ADL; 17-items), function in sport/recreation (5-items), and quality of life (4-items) across injury and OA populations. Each subscale item is scored on a 5-point scale and individual subscale items summed and transformed to a 0-100 scale with higher scores indicating better outcome. The KOOS4 which is an average of 4 sub-scales (excluding ADL) is a recommended and accepted primary outcome for ACLR RCTs and was responsive in our proof of concept RCT.
• Incremental cost-utility ratio over 6 months (efficiency outcome) — Incremental cost-utility ratio at 6 months
  To assess SOARs value for money (health systems perspective) we will estimate the incremental cost/mean change in Quality-Adjusted Life Years (QALY) gained by SOAR versus CONTROL at 6 months. Costs will be estimated with the Health Resource Utilization questionnaire (HRU) as the study population often uses resources not captured in administrative data and evidence of good agreement between administrative and prospectively collected HRU data. The HRU captures provider visits, hospital admissions, lab and diagnostic tests and medication use. QALYs will be estimated from health-related quality of life (EQ-5D-5L) using area under the curve analysis. The EQ-5D-5L is widely used for cost-utility analyses in OA, and assesses 5 levels across 5 health domains to produce a health state profile using Canadian conversion tariffs.
• Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants) — Percent fidelity at 6 months (physiotherapist participants)
  A 40-item fidelity checklist, refined in our proof-of-concept RCT, will be applied to all video-recorded 1:1 counseling sessions for 4 participants per PT, and the median % fidelity for each PT and checklist item reported. Items reaching ≤70% will be identified and inform the development of PT training modules to facilitate future evaluation and implementation.

Trial sites (2)

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