A Multicentre, Double-Blind, Randomised, Non-Inferiority Trial of a Novel Single-Injection Intra-Articular HMDA-Cross-Linked Hyaluronate Gel for Knee Osteoarthritis
Bibliographic record
Abstract
Background/Objectives: This Phase 3, randomised, double-blind, multicentre trial evaluated the efficacy and safety of a novel hyaluronic acid hydrogel cross-linked with hexamethylenediamine (HMDA-HA) compared to a conventional 1,4-butanediol diglycidyl ether cross-linked HA (BDDE-HA) in patients with mild-to-moderate knee osteoarthritis (OA). Methods: A total of 223 adults (mean age 63.5 years; 167 women) with Kellgren–Lawrence (KL) grade I–III knee OA were randomised 1:1 to receive two intra-articular injections of HMDA-HA or BDDE-HA at baseline and at 24 weeks. The primary endpoint was changes from baseline in weight-bearing pain (WBP) on a 100 mm visual analogue scale (VAS) at Week 12, assessed in the per-protocol population. A non-inferiority margin of 10 mm was predefined. Secondary outcomes included global assessments, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index scores, responder rates, and rescue medication use [ClinicalTrials.gov: NCT06307847]. Results: At Week 12, least squares mean change (standard error [SE]) in WBP was −23.72 (1.88) mm in the HMDA-HA group (n = 83) and −25.99 (1.76) mm in the BDDE-HA group (n = 95), yielding a difference of 2.26 mm (95% confidence interval [CI]: −2.83 to 7.34; p = 0.3825), thus demonstrating the non-inferiority of HMDA-HA to BDDE-HA. Secondary outcomes were comparable between groups. A total of 136 adverse events were reported: 44 (41.1%) in the HMDA-HA group and 32 (28.1%) in the BDDE-HA group, with no treatment-related adverse drug reactions. Conclusions: A single-injection intra-articular regimen of HMDA-HA was effective and safe for the treatment of adult patients with mild-to-moderate knee OA.
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".