A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee
Bibliographic record
Abstract
Background and Objective: To perform an integrated analysis of 2 randomized controlled trials (RCTs) to assess the efficacy and safety of a single intra-articular injection of Gel-200 compared with phosphate buffered saline (PBS) for treatment of osteoarthritis of the knee. Methods: Data from the intention-to-treat (ITT) populations of both RCTs were pooled for this integrated analysis. Mean changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscores were assessed using a longitudinal model; treatment differences were compared between intra-articular Gel-200 and PBS injections. Analyses included secondary outcome measures repeated at individual time points. The safety populations of both RCTs were pooled for an integrated safety analysis to compare adverse events (AEs). Results: The pooled ITT population included 1184 subjects (649 Gel-200; 535 PBS); demographic characteristics were similar between treatment groups. Mean improvements in pain subscores from baseline to week 12 were −24.7 mm in Gel-200 and −21.8 mm in PBS groups, a statistically significant treatment group difference of −2.9 mm ( P = .047). From weeks 3 to 26, mean improvements from baseline in pain subscores were −23.8 mm with Gel-200 and −20.8 mm with PBS; this treatment group difference of −3.0 mm was statistically significant ( P = .017). The rate of AEs was similar between Gel-200 and PBS treatment groups. Conclusion: This integrated analysis demonstrated the efficacy of a single intra-articular injection of Gel-200 compared with PBS for treatment of osteoarthritis of the knee over 26 weeks without major safety concerns. Trial Registration: NCT00449696 and NCT00450112.
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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 | 0.078 | 0.140 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.018 | 0.033 |
| Bibliometrics | 0.005 | 0.004 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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 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".