Stopping OsteoARthritis After an ACL Tear

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.

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.

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.

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.

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.

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.

Health resource use costs over 24 months

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

Self-reported knee-related pain, symptoms, function in sport and quality of life over 12 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.

Self-reported knee-related pain, symptoms, function in sport and quality of life over 24 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.

Incremental cost-utility ratio over 12 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 12 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.

Incremental cost-utility ratio over 24 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 24 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.