Stopping OsteoARthritis After an ACL Tear

NCT06195423 | Recruiting DMC

• 1 other identifier: REB# H23-03544
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Knee Injuries; Anterior Cruciate Ligament Rupture; Osteoarthritis, Knee

Keywords

Randomized controlled trial; Post-traumatic osteoarthritis; Knee; Osteoarthritis prevention; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (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.

  Change from baseline KOOS score at 6 months (ACL tear participants)

• Incremental cost-utility ratio over 6 months (efficiency outcome)

  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.

  Incremental cost-utility ratio at 6 months

• Provider adoption of SOAR over 6 months (implementation outcome) (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.

  Percent fidelity at 6 months (physiotherapist participants)

Secondary Outcomes (8)

• Patient Acceptable Symptom State over 6 months (ACL tear participants)

  Change from baseline patient acceptable symptom state score at 6 months (ACL tear participants)

• Self-reported perceived self-management over 6 months (ACL tear participants)

  Change from baseline self-reported perceived self-management at 6 months (ACL tear participants)

• Osteoarthritis MRI features over 24 months (ACL tear participants)

  Change from baseline MRI at 24 months (ACL tear participants)

• Health resource use costs over 24 months

  Health resource use costs over 24 months

• Intervention delivery costs over 6 months

  Intervention delivery costs over 6 months

Other Outcomes (36)

• Self-reported knee-related pain, symptoms, function in sport and quality of life over 12 months (ACL tear participants)

  Change from baseline KOOS score at 12 months (ACL tear participants)

• Self-reported knee-related pain, symptoms, function in sport and quality of life over 24 months (ACL tear participants)

  Change from baseline KOOS score at 24 months (ACL tear participants)

• Incremental cost-utility ratio over 12 months

  Incremental cost-utility ratio at 12 months

Study Arms (2)

Stop OsteoARthritis (SOAR) program

EXPERIMENTAL

Participants with a first-time ACL tear followed by reconstruction surgery randomized to the SOAR program group will complete a 6-month SOAR program (one-time Knee Camp, weekly home-based exercise therapy and physical activity with tracking, weekly 1:1 physiotherapist counseling sessions, and optional weekly group-based exercise classes) Consented trained physiotherapists will deliver the SOAR program throughout the study period to one or more SOAR program participants. Physiotherapists and SOAR participants will be randomly paired.

Behavioral: Stop OsteoARthritis (SOAR) program

Living Well after ACLR

ACTIVE COMPARATOR

Participants with a first-time ACL tear followed by reconstruction surgery randomized to the minimal control (Living Well after ACLR) group will complete a 6-month minimal intervention control program (educational video, workbook, activity tracking, and one 1:1 physiotherapist counseling session).

Behavioral: Living Well after ACLR program

Interventions

Stop OsteoARthritis (SOAR) program BEHAVIORAL

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.

Also known as: SOAR

Stop OsteoARthritis (SOAR) program

Living Well after ACLR program BEHAVIORAL

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.

Also known as: CONTROL

Living Well after ACLR

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Currently live in British Columbia, Canada
• years of age (inclusive)
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• Arthritis Research Centre of Canada: collaborator
• The Arthritis Society, Canada: collaborator

Study Sites (2)

Arthritis Research Canada

Vancouver, British Columbia, V5Y 3P2, Canada

RECRUITING

Sea to Sky Orthopaedics

Whistler, British Columbia, V8E 1A6, Canada

RECRUITING

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  PMID: 40542399 DERIVED

MeSH Terms

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries; Osteoarthritis, Knee; Motor Activity

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Jackie L Whittaker, BScPT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie L Whittaker, BScPT, PhD

CONTACT

604-202-1362; jackie.whittaker@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 RCT.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CA (2)