Efficacy and safety of a single intra-articular injection of mannitol-combined hyaluronan in patients with knee osteoarthritis – A double-blinded randomized clinical study
Bibliographic record
Abstract
BACKGROUND: Treatments for knee osteoarthritis (OA) include injections such as hyaluronic acid (HA), which stabilizes joints but degrades quickly due to reactive oxygen species. The experimental product JETKNEE combines non-crosslinked HA (20 mg/ml) with 0.5 % mannitol, that may slow HA degradation and extend its effect, but with a limited clinical evidence base. OBJECTIVE: To evaluate the efficacy and safety of a single intra-articular injection of JETKNEE versus saline in patients with symptomatic knee OA. METHODS: In this double-blind randomized trial, 132 patients with Kellgren-Lawrence grade 2-3 OA received 2 ml of either JETKNEE or saline. The primary outcome was change in visual analog scale (VAS) pain score at 6 months. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, ultrasound evaluation of cartilage thickness, quadriceps muscle thickness, OA cartilage grading, and adverse events. RESULTS: VAS pain improved significantly in both groups without between-group difference. JETKNEE showed significantly greater improvement in WOMAC pain, function, and total scores across all time points (P < 0.05). Lequesne index improved more rapidly at early visits. No significant differences were observed in ultrasound findings or patient satisfaction. Adverse events were more frequent in the JETKNEE group but were mostly mild. CONCLUSION: A single injection of JETKNEE did not show superiority to placebo in the primary outcome (VAS pain), but demonstrated improvements in secondary functional outcomes for 6 months in patients with 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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 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".