Effect of polymerized‐type I collagen in knee osteoarthritis. II. <i>In vivo</i> study
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
BACKGROUND: Polymerized-Type I Collagen (Polymerized-Collagen) is an anti-inflammatory and a tissue regenerator biodrug. The aim of the study was to evaluate the efficacy and safety of intra-articular injections of Polymerized-Collagen in patients with knee osteoarthritis (OA). METHODS AND DESIGN: Patients (n=53) were treated with 12 intra-articular injections of 2 mL of Polymerized-Collagen (n=27) or 2 mL of placebo (n=26) during 6 months. Follow up period was 6 months. The primary endpoints included Western Ontario and McMaster University Osteoarthritis Index, Lequesne index, and pain intensity on a visual analogue scale (VAS). Secondary outcomes were patient global score, investigator global score and drug evaluation. Clinical improvement was determined if the decrease in pain exceeds 20 mm on a VAS and patients achieved at least 20% of improvement from baseline. Urinary levels of C-terminal crosslinking telopeptide of collagen type II (CTXII) and serum high-sensitivity C-reactive protein (hsCRP) were determined by enzyme immunoassays. Statistical analysis was performed by intention to treat. RESULTS: Polymerized-Collagen was safe and well tolerated. Patients had a statistically significant improvement (P<0.05) from baseline vs. Polymerized-Collagen and vs. placebo at 6 months in: Lequesne Index (13.1+/-0.5 vs. 7.1+/-0.7 vs. 9.6+/-0.8; P=0.027), WOMAC (9.0+/-0.5 vs. 4.0+/-0.6 vs. 5.80+/-0.8; P=0.032), patient VAS (60.0+/-2.6 vs. 20.6+/-2.4 vs. 36.1+/-4.5; P=0.003), physician VAS (49.8+/-1.9 vs. 16.8+/-2.9 vs. 29.8+/-2.9; P=0.002), patient global score (1.08+/-0.1 vs. 2.7+/-0.1 vs. 1.9+/-0.2; P=0.028) and analgesic usage (30.1+/-9.4 vs. 11.0+/-3.4 vs. 17.9+/-4.9; P=0.001). This improvement was persistent during the follow up. A threefold increase in CTXII was determined in placebo group. No differences were found on hs CRP and incidence of adverse events between groups. CONCLUSION: Polymerized-Collagen is safe and effective in the treatment of knee OA.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it