Multicenter, PrOspective, Randomized, Controlled Trial Comparing GenIcular Artery EmbOlization Using Embosphere Microspheres to Corticosteroid iNjections for the Treatment of Symptomatic Knee Osteoarthritis: MOTION Study Protocol Summary
Bibliographic record
Abstract
PURPOSE: Corticosteroid injections are commonly used to treat symptomatic knee osteoarthritis; however, pain relief is usually transient. Genicular artery embolization (GAE) has shown promise as an effective minimally invasive intervention to alleviate symptomatic knee osteoarthritis. The MOTION study is being conducted to compare outcomes following GAE versus corticosteroid injection. MATERIALS AND METHODS: This is an international, multicenter, randomized controlled investigational device exemption (IDE) study enrolling adults (≥ 21 years old) with symptomatic knee osteoarthritis (Kellgren-Lawrence grades 1-4) across ≥ 45 centers worldwide. Patients will be randomized 1:1 to receive GAE with Embosphere® Microspheres (Merit Medical Systems, Inc.) or corticosteroid injections. The primary efficacy measure is clinical success at 6 months, defined as ≥ 50% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. The primary safety measure is the proportion of patients free from treatment-related safety event(s) through 6-month post-index procedure (GAE or corticosteroid injection). Following the 6-month visit, patients in either cohort who do not achieve clinical success may crossover to the other study arm. Additional study measures will assess safety and efficacy outcomes throughout the 24-month follow-up period. The target sample size is 264 (132 per arm) and is based on the number of patients needed to confirm superior efficacy of GAE versus corticosteroid injections and non-inferiority with respect to safety. The overall study power is > 80%. DISCUSSION: Findings from the MOTION study are expected to provide information on the magnitude of the therapeutic benefits associated with GAE versus standard of care over 24 months. TRIAL REGISTRATION: NCT05818150.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.009 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.021 | 0.003 |
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 source (direct Gemma or distilled Codex), 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".