Intra-Articular Hyaluronic Acid for Knee Osteoarthritis: A Postmarket, Open-Label, Long-Term Historical Control Study with Analysis Detailed per Krellgren-Lawrence Radiologic Osteoarthritis Scale Grade
Bibliographic record
Abstract
Intra-articular injections of hyaluronic acid—also called viscosupplementation (VS)—is frequently used for the symptomatic treatment of knee osteoarthritis, a painful and debilitating long-term disease, affecting an important fraction of elderly populations. Severity of knee osteoarthritis is generally described by Kellgren-Lawrence (KL) radiological classification. VS has been widely studied in many clinical trials; however, the results are rarely analyzed in detail according to KL grade. A large, clinical, open-label study was performed in 2004–2007 on 1177 patients with knee osteoarthritis, each treated with VS consisting of 3 injections of Arthrum H 2% (LCA Pharmaceutical, Chartres, France). The characteristics of the patients at baseline included demographic profile, body mass index, KL grade, and clinical scores for pain and function using the Western Ontario and McMaster Universities index. Follow-up visits were at 3, 6, and 9 months after VS procedure. This large database was entirely reprocessed in 2019 to provide a separate analysis per KL grade, complemented by the assessment of the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International rates (%) of responders to the treatment. The analysis was carried out for both intention-to-treat and per-protocol completer populations. A primary outcome in the intention-to-treat analysis, variations of the Western Ontario and McMaster Universities index pain subscore from inclusion to the end of the study were 19.8, 19.8, 17.8, and 14.2 for KL grade I to KL grade IV patients, respectively, on a 0 to 100 scale. In the per-protocol analysis, under the same conditions, the variations were 20.6, 19.9, 17.1, and 11.7. All results were significant (P < 0.001) and clinically relevant for each KL grade. Significant improvements were also observed for the Western Ontario and McMaster Universities index function subscore and for the other secondary outcomes. The Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International responders rate reached 72% to 82% for KL grade I through III patients at Month 6 and Month 9. For KL grade IV patients, the maximum rate reached was 47.7% at Month 6. There was evidence that KL grade is a critical parameter, particularly if KL grade IV is present. Other parameters such as gender, body mass index, and age were not identified as prognostic factors of response to VS based on χ2 and odds ratio (95% CI) testing. Detailed analysis by KL grade supports that VS treatment with Arthrum H 2% applies to a large variety of patients with knee osteoarthritis.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".