Intra-articular administration of hylan G-F 20 in patients with symptomatic hip osteoarthritis: tolerability and effectiveness in a large cohort study in clinical practice.

Abstract

OBJECTIVE:

This prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response.

RESEARCH DESIGN AND METHODS:

Patients presenting with symptomatic hip OA received one 2 mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100 mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study. MAIN OUTCOME MEASURES;

RESULTS:

250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points (p < 0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients < 75 years of age reporting better outcomes.

CONCLUSIONS:

This study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.

• Authors: Alberto Migliore, Sandro Tormenta, Umberto Massafra, Emanuele Bizzi, Francesca Iannessi, Andrea Alimonti, Mauro Granata
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 24 Issue 5 Pg. 1309-16 (May 2008) ISSN: 1473-4877 [Electronic] England
• PMID: 18373891 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• hylan
• Hyaluronic Acid

Topics

• Aged
• Aged, 80 and over
• Cohort Studies
• Confidence Intervals
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Hyaluronic Acid (administration & dosage, analogs & derivatives)
• Injections, Intra-Articular
• Male
• Middle Aged
• Osteoarthritis, Hip (diagnostic imaging, drug therapy, physiopathology)
• Pain Measurement (drug effects)
• Prospective Studies
• Range of Motion, Articular (drug effects, physiology)
• Severity of Illness Index
• Statistics, Nonparametric
• Treatment Outcome
• Ultrasonography, Doppler