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Knee InjuriesSOARNCT06195423

Stopping OsteoARthritis After an ACL Tear

A study testing Stop OsteoARthritis (SOAR) program and Living Well after ACLR program in people with Knee Injuries and Anterior Cruciate Ligament Rupture, run by University of British Columbia at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years
What is being tested?
Stop OsteoARthritis (SOAR) program and Living Well after ACLR program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
2 sitesCanada
Study dates
1 May 2024to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jackie L Whittaker, BScPT, PhD contact

604-202-1362

jackie.whittaker@ubc.ca

Canada2 sites, 2 recruiting

  • Arthritis Research Canada

    Vancouver, British Columbia, V5Y 3P2

    Jackie Whittaker, PT, PhD, 604 202 1362

    Recruiting

  • Sea to Sky Orthopaedics

    Whistler, British Columbia, V8E 1A6

    Alex Brooks-Hill, MD, 604 9054075

    Recruiting

Other trials in Canada

About this study

Official title: The Stop Osteoarthritis (SOAR) Hybrid Effectiveness-Implementation Type 1 Randomized Controlled Trial for Young People At-High-Risk of Early Onset Knee Osteoarthritis

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.

Read the detailed description

PURPOSE: Assess the effectiveness, efficiency, and implementation of a 6-month evidence-informed, digital (online), education and exercise-therapy program (SOAR - Stop OsteoARthritis) versus a minimal intervention control for people aged 16-35 years at risk of early-onset knee osteoarthritis (OA) due to a first time Anterior Cruciate Ligament Reconstruction (ACLR).

OBJECTIVES:

Primary Effectiveness Objective: Assess if self-reported knee pain, symptoms, function, and QoL (average of the Knee injury and OA Outcome Score pain, other symptoms, function in sport and recreation, and quality of life subscale scores; KOOS4) of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL at 6 (primary end-point), 12, and 24 months.

Primary Efficiency Objective: Assess the incremental cost-utility ratio of SOAR compared CONTROL (6, 12, 24 months)

Primary Implementation Objective: Assess provider adoption of the SOAR program.

Secondary Effectiveness Objectives:

  1. Assess if the perceived self-management of people at risk of knee OA who receive SOAR is superior to those receiving a minimal intervention CONTROL (6, 12, 24 months)
  2. Assess if the percentage of SOAR group participants who achieve a Patient Acceptable Symptom State (PASS) for knee-related pain, other symptoms, function in daily living, function in sport and recreation, and quality of life is superior to CONTROL (6, 12, 24 months)
  3. Assess if knee OA MRI features of SOAR group participants are superior to CONTROL (24 months)

Secondary Efficiency Objectives:

  1. Describe the health resource use of SOAR and CONTROL participants (24 months)
  2. Describe SOAR program delivery costs

Secondary Implementation Objectives:

  1. Describe provider perceived barriers and facilitators of SOAR delivery
  2. Describe participants' perceived barriers and facilitators of SOAR delivery
  3. Describe features of physiotherapy (PT) counseling that promote self-management

Exploratory Effectiveness Objectives: Explore the superiority of SOAR to CONTROL on the following outcomes (at 6, 12, and 24 months);

  1. Patient-specific function
  2. Knee-related self-efficacy
  3. Knee-related fear of movement and re-injury
  4. Knee extensor strength
  5. Knee flexor strength
  6. Physical activity,
  7. Health-related quality-of-life
  8. Adiposity
  9. Early cartilage degeneration (at 24 months only)

RESEARCH DESIGN:

The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 randomized controlled trial with embedded cost-utility analyses and 1:1 interviews. This multi-focus design (effectiveness, implementation, efficacy) can accelerate research translation to real-world settings (Type 1: main focus-intervention effectiveness; secondary focus-understand implementation context). This design is appropriate as we have shown feasibility and indirect evidence of SOAR effect, the intervention is minimal risk, and there are no fully powered superiority trials to inform non-inferiority or equivalence designs.

The nature of the interventions do not allow for full blinding (physiotherapists cannot be blinded to treatment). We will employ proven methods from our proof-of-concept RCT to reduce allocation (online randomization module with schedule prepared by an arms-length statistician) and confirmation bias (outcome assessors and data analysts will be blinded to allocation).

STATISTICAL ANALYSES:

Primary analyses will be intent-to-treat (by randomization). Data missing more than 5% will be imputed using multiple imputations by chained equations to avoid bias. To ensure best practice, all outcome and demographic/prognostic variables will be included in imputation equations.

Demographics: Descriptive statistics will be calculated for demographic and potentially prognostic variables (time since injury and ACLR, concomitant injury, ACLR rehabilitation, graft type, reinjury, co-intervention, SES) and observed differences considered or controlled for when interpreting findings.

Effectiveness: SOAR superiority will be assessed with a generalized linear mixed regression model (GLMM) for the primary outcome (KOOS4 at 6 months) adjusted for baseline measure, time since ACLR, and sex. Adjusting for continuous time since ACLR versus stratifying improves power. Similar GLMMs will assess SOAR superiority for continuous secondary (PIH) and exploratory (knee extensor strength, adiposity, physical activity) outcomes at stated time points. Mixed effect logistic regression models (adjusted for the same variables as GLMMs) will assess SOAR superiority for binary secondary outcomes (MRI lesion worsening, achieving PASS) at stated time points. Analyses will yield valid results under the missing at random (MAR) assumption. The robustness of estimates to potential MAR assumption violations will be assessed with state-of-art methods.

Sex/Gender: To explore the effect of gender identity (women, man, gender-diverse) and sex (female, male, intersex) on outcome variables and intervention effect, all outcomes will be described by treatment group stratified by gender (KOOS4, Partner in Health Scale, cost-utility, physical activity, quality of life) or sex (MRI, knee extensor strength, adiposity) at all time points. We will estimate GLMMs and report intervention effect estimates stratified by sex (female, male) or gender (woman, man) as exploratory analyses to inform future studies. As 6% of our preliminary proof-of-concept randomized controlled trial participants identified gender diverse, descriptive statistics will also explore differences by cis and diverse gender.

Implementation: The % of physiotherapists achieving ≥85% on the fidelity checklist and checklist items with ≤70% fidelity will be reported. Provider and participants' responses to survey questions asking about barriers and facilitators of SOAR implementation will be summarized. Interview recordings related to identifying features of participant-provider interactions that facilitate self-management will be transcribed and de-identified. Data will be coded using a constant comparative approach, and categories will be developed by comparing and identifying meaningful patterns across codes. High-order themes will elucidate the relationship between categories. We will look for uniqueness by gender and, if found, reanalyze the data with a gender lens. Analysis trustworthiness and credibility will be fostered through data immersion, memoing, reflexive journaling, and team discussions. An audit of analytic decisions will be kept.

Efficiency outcome: Incremental cost-utility ratio will be estimated as (Cost_SOAR - Cost_CONTROL) ⁄(∆QALY_SOAR - ∆QALY_CONTROL) for the intervention and 6-month post-intervention period using nested imputation and nonparametric bootstrapping to model uncertainty around cost and QALY estimates. The contribution of each cost item to total healthcare resource use will be described by group, gender, and compliance (full, partial).

Being tested
Stop OsteoARthritis (SOAR) program, Living Well after ACLR program
Keywords
Randomized controlled trial, Post-traumatic osteoarthritis, Knee, Osteoarthritis prevention, Exercise, Rehabilitation
Medical subject headings
Knee Injuries, Anterior Cruciate Ligament Injuries, Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stop OsteoARthritis (SOAR) programBehavioural

    Also called SOAR

    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 programBehavioural

    Also called CONTROL

    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 groups in NCT06195423
Study groupRoleWhat they receive
Stop OsteoARthritis (SOAR) programExperimentalParticipants 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.
Receives: Behavioral: Stop OsteoARthritis (SOAR) program
Living Well after ACLRActive comparatorParticipants 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).
Receives: Behavioral: Living Well after ACLR program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Incremental cost-utility ratio at 6 months

  3. 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.

    Measured: Percent fidelity at 6 months (physiotherapist participants)

Secondary outcomes (8)

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

    To help interpret the clinical relevance of the KOOS4, the percentage of participants in both study groups to reach KOOS4 and KOOS sub-scale Patient Acceptable Symptom State (PASS) scores (KOOS4 79; pain 89; symptoms 83; ADL 95, sport 72; QoL 73) will be reported.

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

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

    The 12 item Partner in Health Scale will be used to measure perceived self-management (active involvement to self-manage a chronic condition). Each item is scored on a 0-9 point Likert scale. Scores on individual items are summed to produce a total score ranging between 0 and 96, with 0 representing no perceived self-management and 96 representing full perceived self-management. The total time for this questionnaire is 3 minutes. The Partner in Health Scale is valid and reliable across numerous chronic conditions.

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

  3. Osteoarthritis MRI features over 24 months (ACL tear participants)

    MRI features of OA (cartilage defect, bone marrow lesions) are important for early disease staging and common after ACLR. The impact of exercise on these outcomes post-ACLR is unknown. The valid semi-quantitative MRI OA knee score (MOAKS) will be applied to 3D proton-density (PD) gradient MRI sequences (3T scanner, Philips Elition, 8-channel knee coil). Positioning aids will immobilize the knee to ensure consistent scans. Radiology fellows will conduct MOAKS ratings blinded to group allocation. OA feature worsening will be defined as an increase in the size of the lesion using established methods.

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

  4. Health resource use costs over 24 months

    Monthly health resource use costs (HRU) will be reported over the 24-month study period.

    Measured: Health resource use costs over 24 months

  5. Intervention delivery costs over 6 months

    The cost to deliver the SOAR and CONTROL (Living Well with ACLR) interventions will be tracked and reported.

    Measured: Intervention delivery costs over 6 months

  6. Participant perceived barriers and facilitators of program delivery over 6 months (ACL tear participants)

    On completion of the intervention, participants will receive a follow-up survey which will include questions to capture information about their perceived barriers and facilitators of program delivery, and therapeutic alliance with their PT (Consultation and Relational Empathy measure (CARE)).

    Measured: Follow-up surveys will take place at 6 months (ACL tear participants)

  7. Provider perceived barriers and facilitators of program delivery over 6 months (physiotherapist participants)

    After PT's are done delivering the SOAR program they will receive a follow-up survey including questions to capture information about their perceived barriers and facilitators of SOAR program delivery, SOAR and BAP training, confidence in BAP, SMART goal setting, shared decision making, virtual PT delivery, and perceived impacts on patient and clinic flow.

    Measured: Follow-up surveys will take place at 6 months (physiotherapist participants)

  8. Features of PT counselling that promote self-management over 6 months (ACL tear participants)

    Semi-structured 1:1 interviews will be conducted with a purposive maximum variation sample (gender, age, adherence, time since injury) of 15-20 participants. Using video-cued narrative reflection, participants will self-select meaningful exchanges with their PT that promoted self-management while viewing a Knee Camp recording and a random weekly counselling session. Participants will be able to pause and rewind the recording to identify, and elaborate on significant moments. A definition of self-management and context-specific examples will be provided. Probe and prompts will provide elaboration. Field notes will be taken, and interviews recorded. Ongoing analyses will inform sampling, and data collection will cease when no new themes are identified. Video-recorded healthcare interactions are acceptable and provide valuable practice insights. Video-cued interviews yield rich data as participants simultaneously identify, engage and reflect on their lived experience.

    Measured: 1:1 interviews will be conducted at 6 months (ACL tear participants)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start1 May 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 RCT.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06195423
Sponsor's protocol ID
REB# H23-03544
Acronym
SOAR
Status last verified
May 2024
First submitted
22 Dec 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bombardier C, Hawker G, Mosher D. The Impact of Arthritis in Canada: Today and Over the Next 30 Years. Arthritis Alliance of Canada. Fall 2011.

  • Ackerman IN, Bohensky MA, Zomer E, Tacey M, Gorelik A, Brand CA, de Steiger R. The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030. BMC Musculoskelet Disord. 2019 Feb 23;20(1):90. doi: 10.1186/s12891-019-2411-9.

    PubMed 30797228

  • Sharif B, Kopec JA, Wong H, Anis AH. Distribution and Drivers of Average Direct Cost of Osteoarthritis in Canada From 2003 to 2010. Arthritis Care Res (Hoboken). 2017 Feb;69(2):243-251. doi: 10.1002/acr.22933.

    PubMed 27159532

  • Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014 Jul;10(7):437-41. doi: 10.1038/nrrheum.2014.44. Epub 2014 Mar 25.

    PubMed 24662640

  • Sharif B, Garner R, Sanmartin C, Flanagan WM, Hennessy D, Marshall DA. Risk of work loss due to illness or disability in patients with osteoarthritis: a population-based cohort study. Rheumatology (Oxford). 2016 May;55(5):861-8. doi: 10.1093/rheumatology/kev428. Epub 2016 Jan 11.

    PubMed 26759430

  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560

  • Tugwell P, Bennett KJ, Sackett DL, Haynes RB. The measurement iterative loop: a framework for the critical appraisal of need, benefits and costs of health interventions. J Chronic Dis. 1985;38(4):339-51. doi: 10.1016/0021-9681(85)90080-3.

    PubMed 3923014

  • Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.

    PubMed 20660401

  • Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

    PubMed 9699158

  • Runhaar J, Schiphof D, van Meer B, Reijman M, Bierma-Zeinstra SM, Oei EH. How to define subregional osteoarthritis progression using semi-quantitative MRI osteoarthritis knee score (MOAKS). Osteoarthritis Cartilage. 2014 Oct;22(10):1533-6. doi: 10.1016/j.joca.2014.06.022.

    PubMed 25278062

  • Hunter DJ, Guermazi A, Lo GH, Grainger AJ, Conaghan PG, Boudreau RM, Roemer FW. Evolution of semi-quantitative whole joint assessment of knee OA: MOAKS (MRI Osteoarthritis Knee Score). Osteoarthritis Cartilage. 2011 Aug;19(8):990-1002. doi: 10.1016/j.joca.2011.05.004. Epub 2011 May 23.

    PubMed 21645627

  • Truong LK, Mosewich AD, Miciak M, Pajkic A, Silvester-Lee T, Li LC, Whittaker JL. "I feel I'm leading the charge." Experiences of a virtual physiotherapist-guided knee health program for persons at-risk of osteoarthritis after a sport-related knee injury. Osteoarthr Cartil Open. 2022 Dec 27;5(1):100333. doi: 10.1016/j.ocarto.2022.100333. eCollection 2023 Mar.

    PubMed 36685259

  • Whittaker JL, Truong LK, Silvester-Lee T, Losciale JM, Miciak M, Pajkic A, Le CY, Hoens AM, Mosewich AD, Hunt MA, Li LC, Roos EM. Feasibility of the SOAR (Stop OsteoARthritis) program. Osteoarthr Cartil Open. 2022 Jan 28;4(1):100239. doi: 10.1016/j.ocarto.2022.100239. eCollection 2022 Mar.

    PubMed 36474472

  • Whittaker JL, Truong LK, Losciale JM, Silvester-Lee T, Miciak M, Pajkic A, Le CY, Hoens AM, Mosewich A, Hunt MA, Li LC, Roos EM. Efficacy of the SOAR knee health program: protocol for a two-arm stepped-wedge randomized delayed-controlled trial. BMC Musculoskelet Disord. 2022 Jan 25;23(1):85. doi: 10.1186/s12891-022-05019-z.

    PubMed 35078446

  • Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

    PubMed 20053272

Questions about this trial

What is this clinical trial studying?

A study testing Stop OsteoARthritis (SOAR) program and Living Well after ACLR program in people with Knee Injuries and Anterior Cruciate Ligament Rupture, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jackie L Whittaker, BScPT, PhD (604-202-1362, jackie.whittaker@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06195423, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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