Safety and Efficacy of Intra-articular Sodium Hyaluronate (Hyalgan<sup>®</sup>) in a Randomized, Double-Blind Study for Osteoarthritis of the Ankle
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Bibliographic record
Abstract
BACKGROUND: The potential benefit of hyaluronans in alleviating pain associated with osteoarthritis (OA) in joints other than the knee is of increasing interest. This double-blind, randomized, controlled study examined the safety and efficacy of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain associated with ankle OA. MATERIALS AND METHODS: Thirty consecutive patients with ankle OA documented by X-ray were randomized to treatment with five weekly injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 mL (control) in the tibiotalar joint. The primary endpoint was pain on movement and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after injection (a 100-mm visual analog scale [VAS]). Additional measures included the Western Ontario and McMaster Universities (WOMAC) OA Index and patient global assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months and 6 months; and all reported adverse events (AEs). RESULTS: The study groups differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL and 73% of the control patients completed the study. At Month 3, the primary endpoint of the study, the HYL group demonstrated a significantly greater improvement from baseline in AOS total score than did the control group (HYL: -17.4 +/- 5.0 mm; CONTROL: -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was low, with no significant differences between the groups. There were no post-injection flares. CONCLUSION: Our study suggests that sodium hyaluronate may be a safe and effective option for pain associated with ankle OA, although larger studies are needed.
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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 | 0.000 | 0.000 |
| 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