Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT06195423

Conditions

Knee Injuries

Anterior Cruciate Ligament Rupture

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

Interventions

Stop OsteoARthritis (SOAR) program

Living Well after ACLR program

Study Details

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

Study ID

NCT06195423

Start date

May 1, 2024

Status verified date

May, 2024

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 35

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stop OsteoARthritis (SOAR) program

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.

active comparator: Living Well after ACLR

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).

Interventions

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.

Primary outcome measure

  • Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants) [ Time Frame: Change from baseline KOOS score at 6 months (ACL tear participants) ]
  • Incremental cost-utility ratio over 6 months (efficiency outcome) [ Time Frame: Incremental cost-utility ratio at 6 months ]
  • Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants) [ Time Frame: Percent fidelity at 6 months (physiotherapist participants) ]

Central Contacts and Locations

Central contacts

Jackie L Whittaker, BScPT, PhD

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

Locations

Arthritis Research Canada

Recruiting

Vancouver, British Columbia, Canada, V5Y 3P2

Contacts

Jackie Whittaker, PT, PhD

604 202 1362

Sea to Sky Orthopaedics

Recruiting

Whistler, British Columbia, Canada, V8E 1A6

Contacts

Alex Brooks-Hill, MD

604 9054075

More Information

Sponsor

University of British Columbia

Last update posted

May 10, 2024

Last verified

May, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-10.