Digital education and exercise therapy versus minimal intervention for young people at high risk of early onset knee osteoarthritis after ACL reconstruction: a study protocol for the Stop OsteoARthritis (SOAR) randomized controlled trial
Bibliographic record
Abstract
Abstract Background People who tear their anterior cruciate ligament and have reconstruction surgery (ACLR) are at elevated risk of inactivity, obesity, and early-onset knee osteoarthritis. Consensus recommendations to prevent post-traumatic knee osteoarthritis include person-centered education and exercise-based treatments. The effectiveness of these recommendations is unknown. This study will assess if a digital education and exercise therapy intervention is superior to minimal intervention for improving knee-related symptoms, function, and quality of life in young people after ACLR. Methods The Stop OsteoARthritis (SOAR) study is a parallel, two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 randomized controlled trial. After baseline testing, 166 participants aged 16–35 years, 9–36 months past, a first-time ACLR with ongoing symptoms will be randomly allocated to one of two treatment groups (1:1 ratio, stratified by sex). Ongoing symptoms will be defined as not meeting a Patient Acceptable Symptom State (PASS) on the averaged Knee injury and Osteoarthritis Outcome Score pain, symptoms function in sport and recreation, and quality-of-life subscales (KOOS 4 < 79). Participants randomized to the experimental intervention will receive a digital (remote videoconferencing) 6-month program of group-based learning, individualized weekly home-based exercise therapy and physical activity program with tracking, and 1:1 physiotherapist-guided counseling. Participants randomized to the minimal intervention control group will receive an educational recording, best-practice guide for ACLR rehabilitation, one videoconferencing session, and tracking. The primary effectiveness outcome is the between-group difference in KOOS 4 change from baseline to 6-months, with secondary endpoints at 12- and 24months. Secondary effectiveness outcomes include differences in the change of individual KOOS subscale scores, proportions of participants achieving KOOS subscale PASS scores, perceived self-management, and MRI features of knee OA. We will also assess secondary implementation (perceived barriers and facilitators of SOAR delivery), secondary efficiency (incremental cost-utility ratio), and exploratory outcomes. Missing data will be imputed and blinded intention-to-treat analyses performed. Discussion By assessing the effect, implementation, and efficiency of a digital education and exercise-based intervention designed to improve the knee health of young people at increased risk of knee osteoarthritis, this study will provide a basis for future scale-up to help curb the mounting burden of osteoarthritis. Trial registration ClinicalTrials.gov NCT06195423. Registered on December 22, 2023.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".