Clinical trial NCT06195423: Stopping OsteoARthritis After an ACL Tear
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Injuries
Anterior Cruciate Ligament Rupture
Osteoarthritis, Knee
Keywords: Randomized controlled trial
Post-traumatic osteoarthritis
Knee
Osteoarthritis prevention
Exercise
Rehabilitation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Arthritis Research Centre of Canada
name: The Arthritis Society, Canada
First posted: 2024-01-08
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed trial is a two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 RCT.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Self-reported knee-related pain, symptoms, function in sport and quality of life over 6 months (effectiveness outcome) (ACL tear participants)
timeFrame: Change from baseline KOOS score at 6 months (ACL tear participants)
measure: Incremental cost-utility ratio over 6 months (efficiency outcome)
timeFrame: Incremental cost-utility ratio at 6 months
measure: Provider adoption of SOAR over 6 months (implementation outcome) (physiotherapist participants)
timeFrame: Percent fidelity at 6 months (physiotherapist participants)
Secondary outcomes:
measure: Patient Acceptable Symptom State over 6 months (ACL tear participants)
timeFrame: Change from baseline patient acceptable symptom state score at 6 months (ACL tear participants)
measure: Self-reported perceived self-management over 6 months (ACL tear participants)
timeFrame: Change from baseline self-reported perceived self-management at 6 months (ACL tear participants)
measure: Osteoarthritis MRI features over 24 months (ACL tear participants)
timeFrame: Change from baseline MRI at 24 months (ACL tear participants)
measure: Health resource use costs over 24 months
timeFrame: Health resource use costs over 24 months
measure: Intervention delivery costs over 6 months
timeFrame: Intervention delivery costs over 6 months
measure: Participant perceived barriers and facilitators of program delivery over 6 months (ACL tear participants)
timeFrame: Follow-up surveys will take place at 6 months (ACL tear participants)
measure: Provider perceived barriers and facilitators of program delivery over 6 months (physiotherapist participants)
timeFrame: Follow-up surveys will take place at 6 months (physiotherapist participants)
measure: Features of PT counselling that promote self-management over 6 months (ACL tear participants)
timeFrame: 1:1 interviews will be conducted at 6 months (ACL tear participants)
Other outcomes:
measure: Self-reported knee-related pain, symptoms, function in sport and quality of life over 12 months (ACL tear participants)
timeFrame: Change from baseline KOOS score at 12 months (ACL tear participants)
measure: Self-reported knee-related pain, symptoms, function in sport and quality of life over 24 months (ACL tear participants)
timeFrame: Change from baseline KOOS score at 24 months (ACL tear participants)
measure: Incremental cost-utility ratio over 12 months
timeFrame: Incremental cost-utility ratio at 12 months
measure: Incremental cost-utility ratio over 24 months
timeFrame: Incremental cost-utility ratio at 24 months
measure: Patient Acceptable Symptom State over 12 months (ACL tear participants)
timeFrame: Change from baseline Patient Acceptable Symptom State score at 12 months (ACL tear participants)
measure: Patient Acceptable Symptom State over 24 months (ACL tear participants)
timeFrame: Change from baseline Patient Acceptable Symptom State score at 24 months (ACL tear participants)
measure: Self-reported perceived self-management over 12 months (ACL tear participants)
timeFrame: Change from baseline self-reported perceived self-management at 12 months (ACL tear participants)
measure: Perceived self-management over 24 months (ACL tear participants)
timeFrame: Change from baseline self-reported perceived self-management at 24 months (ACL tear participants)
measure: Self-reported function over 6 months (ACL tear participants)
timeFrame: Change from baseline self-reported function at 6 months (ACL tear participants)
measure: Self-reported function over 12 months (ACL tear participants)
timeFrame: Change from baseline self-reported function at 12 months (ACL tear participants)
measure: Self-reported function over 24 months (ACL tear participants)
timeFrame: Change from baseline self-reported function at 24 months (ACL tear participants)
measure: Self-reported knee-specific self-efficacy over 6 months (ACL tear participants)
timeFrame: Change from baseline self-reported knee-specific self-efficacy at 6 months (ACL tear participants)
measure: Self-reported knee-specific self-efficacy over 12 months (ACL tear participants)
timeFrame: Change from baseline self-reported knee-specific self-efficacy at 12 months (ACL tear participants)
measure: Self-reported knee-specific self-efficacy over 24 months (ACL tear participants)
timeFrame: Change from baseline self-reported knee-specific self-efficacy at 24 months (ACL tear participants)
measure: Self-reported fear of movement and re-injury over 6 months (ACL tear participants)
timeFrame: Change from baseline self-reported fear of movement and re-injury at 6 months (ACL tear participants)
measure: Self-reported fear of movement and re-injury over 12 months (ACL tear participants)
timeFrame: Change from baseline self-reported fear of movement and re-injury at 12 months (ACL tear participants)
measure: Self-reported fear of movement and re-injury over 24 months (ACL tear participants)
timeFrame: Change from baseline self-reported fear of movement and re-injury at 24 months (ACL tear participants)
measure: Change in Knee Extension Power over 6 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 6 months (ACL tear participants)
measure: Change in Knee Extension Power over 12 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 12 months (ACL tear participants)
measure: Change in Knee Extension Power over 24 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 24 months (ACL tear participants)
measure: Change in Knee Flexion Power over 6 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 6 months (ACL tear participants)
measure: Change in Knee Flexion Power over 12 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 12 months (ACL tear participants)
measure: Change in Knee Flexion Power over 24 months (ACL tear participants)
timeFrame: Change from baseline knee extensor muscle power at 24 months (ACL tear participants)
measure: Change in Daily Average Moderate to Vigorous Physical Activity over 6 months (ACL tear participants)
timeFrame: Change from baseline daily average moderate to vigorous physical activity at 6 months (ACL tear participants)
measure: Change in Daily Average Moderate to Vigorous Physical Activity over 12 months (ACL tear participants)
timeFrame: Change from baseline daily average moderate to vigorous physical activity at 12 months (ACL tear participants)
measure: Change in Daily Average Moderate to Vigorous Physical Activity over 24 months (ACL tear participants)
timeFrame: Change from baseline daily average moderate to vigorous physical activity at 24 months (ACL tear participants)
measure: Change in Self-Reported Physical Activity over 6 months (ACL tear participants)
timeFrame: Change from baseline self-reported physical activity at 6 months (ACL tear participants)
measure: Change in Self-Reported Physical Activity over 12 months (ACL tear participants)
timeFrame: Change from baseline self-reported physical activity at 12 months (ACL tear participants)
measure: Change in Self-Reported Physical Activity over 24 months (ACL tear participants)
timeFrame: Change from baseline self-reported physical activity at 24 months (ACL tear participants)
measure: Change in Health-Related Quality of Life over 6 months (ACL tear participants)
timeFrame: Change from baseline health-related quality of life at 6 months (ACL tear participants)
measure: Change in Health-Related Quality of Life over 12 months (ACL tear participants)
timeFrame: Change from baseline health-related quality of life at 12 months (ACL tear participants)
measure: Change in Health-Related Quality of Life over 24 months (ACL tear participants)
timeFrame: Change from baseline health-related quality of life at 24 months (ACL tear participants)
measure: Change in Fat Mass Index over 6 months (ACL tear participants)
timeFrame: Change from baseline fat mass index at 6 months (ACL tear participants)
measure: Change in Fat Mass Index over 12 months (ACL tear participants)
timeFrame: Change from baseline fat mass index at 12 months (ACL tear participants)
measure: Change in Fat Mass Index over 24 months (ACL tear participants)
timeFrame: Change from baseline fat mass index at 24 months (ACL tear participants)
measure: Change in Knee Cartilage Health over 24 months (ACL tear participants)
timeFrame: Change from baseline knee cartilage health at 24 months (ACL tear participants)
Locations:
city: Vancouver
country: Canada
facility: Arthritis Research Canada
state: British Columbia
city: Whistler
country: Canada
facility: Sea to Sky Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jackie L Whittaker, BScPT, PhD
role: PRINCIPAL_INVESTIGATOR
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