SOAR Program for Preventing Osteoarthritis After ACL Tear

(SOAR Trial)

Recruiting at 1 trial location

Overseen By Jackie L Whittaker, BScPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Inflammatory arthritis, Pregnancy, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 6 months

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual education and exercise program, called Stop OsteoARthritis (SOAR), can improve knee health and prevent osteoarthritis in individuals who tore their ACL and underwent surgery 9 to 36 months ago. Participants will be randomly assigned to either the SOAR program or a minimal intervention control program to assess which is more effective in reducing knee pain and improving function and quality of life. Researchers will use MRIs to examine knee cartilage and evaluate the cost-effectiveness of the SOAR program. Individuals who experienced an ACL tear and surgery within the last 36 months and are not currently receiving knee care might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance knee health for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the SOAR program is safe for preventing osteoarthritis after ACL tear?

Research shows that the Stop OsteoARthritis (SOAR) program, which includes online learning and exercise therapy, is generally easy for participants to handle. Studies on similar programs have found that people often experience stronger knees and improved knee health without major side effects. Although specific safety data for the SOAR program is not available, its focus on exercise and education is considered low-risk. Exercise therapy is a common and safe method used in physical rehabilitation. Overall, evidence suggests that the SOAR program should be safe for most people, especially since it uses well-known methods for improving knee health after injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SOAR program because it offers a comprehensive approach to preventing osteoarthritis after an ACL tear, which current standard care options, like surgery and physical therapy, don’t specifically address long-term joint health. The SOAR program combines a unique blend of interventions, including a one-time Knee Camp, consistent home-based exercise therapy, and regular physiotherapist guidance, tailored to each participant's needs. This integrated approach not only aims to improve recovery outcomes but also actively targets the prevention of osteoarthritis, potentially changing the trajectory of joint health after ACL injuries.

What evidence suggests that the SOAR program is effective for preventing osteoarthritis after an ACL tear?

Research has shown that the Stop OsteoARthritis (SOAR) program, which participants in this trial may receive, can improve knee health in individuals who have had ACL tears and surgery. A previous study found the SOAR program more effective in boosting knee strength and reducing symptoms compared to minimal activity. Participants reported better knee health after completing the program's exercise and education sessions. The program emphasizes exercises and education to prevent worsening knee problems, potentially lowering the risk of developing osteoarthritis. Early findings suggest this approach could maintain knee function and enhance quality of life. ^{1 4 6 7 8}

Who Is on the Research Team?

Jackie L Whittaker, BScPT, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for young adults aged 16-35 in British Columbia who had ACL reconstruction surgery 9-36 months ago. Participants should not be currently receiving other knee treatments, have limited knee function as measured by a KOOS4 score, and must have daily internet access to participate in virtual programs.

Inclusion Criteria

You need to have an email address and a computer with internet that you can use every day.

I am between 16 and 35 years old.

You currently live in British Columbia, Canada.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month virtual education and exercise therapy program called Stop OsteoARthritis (SOAR) or a minimal intervention control program

6 months

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6, 12, and 24 months

24 months

Assessments at 6, 12, and 24 months

MRI Assessment

MRI assessments to evaluate knee cartilage degeneration and other OA features

24 months

Baseline and 24-month MRI scans

What Are the Treatments Tested in This Trial?

Interventions

• Stop OsteoARthritis (SOAR) program

Trial Overview

The study compares the SOAR program—a virtual education and exercise therapy—with a minimal intervention control program for improving knee health post-ACL tear. It measures pain relief, symptom improvement, better function, quality of life over time, and uses MRIs to check cartilage changes.

How Is the Trial Designed?

Group I: Stop OsteoARthritis (SOAR) program Experimental Treatment 1 Intervention

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.

Group II: Living Well after ACLR Active Control 1 Intervention

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).

Stop OsteoARthritis (SOAR) program is already approved in Canada for the following indications:

Approved in Canada as SOAR Program for:

• Prevention of osteoarthritis after ACL reconstruction

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Arthritis Research Centre of Canada

Collaborator

Trials

16

Recruited

12,200+

The Arthritis Society, Canada

Collaborator

Trials

27

Recruited

9,700+

Published Research Related to This Trial

Only about 60% of individuals with anterior cruciate ligament (ACL) injuries fully recover, and less than 60% return to their sports after treatment, highlighting the need for improved recovery strategies.

More than 50% of those with ACL injuries develop knee osteoarthritis by middle age, indicating that early intervention is crucial to prevent the onset and progression of posttraumatic osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We Need to Implement Current Evidence in Early Rehabilitation Programs to Improve Long-Term Outcome After Anterior Cruciate Ligament Injury. Risberg, MA., Grindem, H., Øiestad, BE.[2017]

The Osteoarthritis Action Alliance developed 15 consensus recommendations for clinicians to help prevent osteoarthritis after an ACL injury, focusing on strategies like patient education, exercise, and psychological support.

These recommendations aim to raise awareness and encourage early intervention to reduce the long-term burden of osteoarthritis following ACL injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Osteoarthritis After an Anterior Cruciate Ligament Injury: An Osteoarthritis Action Alliance Consensus Statement. Driban, JB., Vincent, HK., Trojian, TH., et al.[2023]

About 50% of individuals who undergo anterior cruciate ligament reconstruction (ACLR) develop knee osteoarthritis (OA) 12-14 years later, with abnormal tibial movement during walking contributing to this risk.

Early ACLR (within 5 days of injury) is associated with a lower incidence of radiographically apparent tibiofemoral OA at 32-37 years follow-up compared to those who do not have the surgery, although both groups experience similar knee symptoms and rates of symptomatic OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction: Frequency, Contributory Elements, and Recent Interventions to Modify the Route of Degeneration. Rodriguez-Merchan, EC., Encinas-Ullan, CA.[2022]

In a study of 276 patients with ACL injuries, 5-year outcomes showed that only 6% developed significant knee osteoarthritis (OA) in the injured knee, indicating that a shared decision-making treatment algorithm may lead to favorable long-term results.

There were no significant differences in knee pain or radiographic outcomes among those who underwent early ACL reconstruction, delayed ACL reconstruction, or progressive rehabilitation alone, suggesting that all three management strategies can be effective in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Rates of Radiographic Knee Osteoarthritis 5 Years After ACL Reconstruction or Rehabilitation Alone: The Delaware-Oslo ACL Cohort Study. Pedersen, M., Grindem, H., Berg, B., et al.[2023]

A significant percentage (50-90%) of individuals who suffer an ACL rupture will develop tibiofemoral osteoarthritis (OA) within 10 years, highlighting the long-term risks associated with this injury.

Radiographic evidence shows that about 50% of individuals experience patellofemoral OA more than 10 years after ACL reconstruction, indicating the need for targeted interventions to address early-onset OA in younger adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patellofemoral Osteoarthritis: Are We Missing an Important Source of Symptoms After Anterior Cruciate Ligament Reconstruction? Culvenor, AG., Crossley, KM.[2017]

A systematic review identified six key components for effective injury prevention programs (IPPs) aimed at reducing the risk of osteoarthritis (OA) after ACL injuries, including lower extremity strengthening, plyometrics, and continual feedback on technique.

The study emphasizes that while balance training is beneficial, it should be combined with other exercises for maximum effectiveness, and stretching and agility exercises can be optional as there is insufficient evidence to recommend them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoarthritis action alliance consensus opinion - best practice features of anterior cruciate ligament and lower limb injury prevention programs. Trojian, T., Driban, J., Nuti, R., et al.[2020]

In a study of 143 adults with recent ACL ruptures, 12% and 27% showed progression of cartilage defects in the medial and lateral tibiofemoral compartments, respectively, indicating early degenerative changes after 2 years.

Key risk factors for these degenerative changes included male sex, pre-existing cartilage defects, bone marrow lesions, joint effusion, and meniscal tears, suggesting that these factors could help identify patients at higher risk for developing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Degenerative Changes in the Knee 2 Years After Anterior Cruciate Ligament Rupture and Related Risk Factors: A Prospective Observational Follow-up Study. van Meer, BL., Oei, EH., Meuffels, DE., et al.[2022]

In a study of 49 ACL-injured knees, significant cartilage degeneration was observed in the medial femoral condyle after 2 years post-injury, indicating a delayed onset of degeneration associated with ACL injuries.

Medial meniscus injuries further increased the risk of cartilage degeneration in the chronic phase, suggesting that early intervention for meniscus injuries may be crucial to prevent long-term joint damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Biochemical Cartilage Change After Anterior Cruciate Ligament Injury Using T1ρ Mapping Magnetic Resonance Imaging. Osaki, K., Okazaki, K., Takayama, Y., et al.[2020]

Citations

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A RANDOMIZED DELAYED-CONTROLLED TRIAL FOR ...

This study aims to: i) describe 11-year outcomes and radiographic osteoarthritis. (ROA) by 5-year ACL continuity status, and ii) investigate the relationship.

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2-Year Injury Rates in the ACL-SPORTS Randomized ...

There were 9 second ACL injuries in the 2 years after ACLR. There was no statistically significant difference in rate or side of second ACL ...