Stopping OsteoARthritis After an ACL Tear
- Conditions
- Knee InjuriesAnterior Cruciate Ligament RuptureOsteoarthritis, Knee
- Interventions
- Behavioral: Living Well after ACLR programBehavioral: Stop OsteoARthritis (SOAR) program
- Registration Number
- NCT06195423
- Lead Sponsor
- University of British Columbia
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Living Well after ACLR Living Well after ACLR program 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 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.
- Primary Outcome Measures
Name Time Method Incremental cost-utility ratio over 6 months (efficiency outcome) Incremental cost-utility ratio at 6 months 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.
Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants) Change from baseline KOOS score at 6 months (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.
Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants) Percent fidelity at 6 months (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.
- Secondary Outcome Measures
Name Time Method Patient Acceptable Symptom State over 6 months (ACL tear participants) Change from baseline patient acceptable symptom state score at 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.
Intervention delivery costs over 6 months Intervention delivery costs over 6 months The cost to deliver the SOAR and CONTROL (Living Well with ACLR) interventions will be tracked and reported.
Participant perceived barriers and facilitators of program delivery over 6 months (ACL tear participants) Follow-up surveys will take place at 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)).
Provider perceived barriers and facilitators of program delivery over 6 months (physiotherapist participants) Follow-up surveys will take place at 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.
Osteoarthritis MRI features over 24 months (ACL tear participants) Change from baseline MRI at 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.
Health resource use costs over 24 months Health resource use costs over 24 months Monthly health resource use costs (HRU) will be reported over the 24-month study period.
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) 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.
Features of PT counselling that promote self-management over 6 months (ACL tear participants) 1:1 interviews will be conducted at 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.
Trial Locations
- Locations (2)
Arthritis Research Canada
🇨🇦Vancouver, British Columbia, Canada
Sea to Sky Orthopaedics
🇨🇦Whistler, British Columbia, Canada