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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the SOAR treatment for preventing osteoarthritis after an ACL tear?

The SOAR treatment includes strategies like exercise, rehabilitation, and psychological skills training, which are recommended by experts to reduce the risk of osteoarthritis after an ACL injury. Additionally, early interventions and coordinated care models are suggested to help slow or prevent the progression of osteoarthritis. ^{1 2 3 4 5}

How is the SOAR treatment different from other treatments for preventing osteoarthritis after an ACL tear?

The SOAR program is unique because it focuses on a comprehensive approach that includes patient education, exercise and rehabilitation, psychological skills training, and coordinated care models to prevent osteoarthritis after an ACL injury, rather than just addressing symptoms or using medication. ^{1 5 6 7 8}

Research Team

Jackie L Whittaker, BScPT, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preventing Osteoarthritis After an Anterior Cruciate Ligament Injury: An Osteoarthritis Action Alliance Consensus Statement. [2023]

2. United States 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. [2023]

3. Iran pubmed.ncbi.nlm.nih.gov

Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction: Frequency, Contributory Elements, and Recent Interventions to Modify the Route of Degeneration. [2022]

4. United States 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. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Characterization of Biochemical Cartilage Change After Anterior Cruciate Ligament Injury Using T1ρ Mapping Magnetic Resonance Imaging. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Patellofemoral Osteoarthritis: Are We Missing an Important Source of Symptoms After Anterior Cruciate Ligament Reconstruction? [2017]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Osteoarthritis action alliance consensus opinion - best practice features of anterior cruciate ligament and lower limb injury prevention programs. [2020]