Tags

Type your tag names separated by a space and hit enter

A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee.
Osteoarthritis Cartilage. 2006 Feb; 14(2):154-62.OC

Abstract

OBJECTIVE

To compare the safety and effectiveness of a high molecular weight hyaluronan produced by biological fermentation (Bio-HA) with those of avian-derived hyaluronan that uses cross-linking to achieve high molecular weight (CL-HA).

DESIGN

This was a prospective, multicenter, randomized, double-blind trial evaluating patients with confirmed osteoarthritis of the knee. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) pain subscale was the primary effectiveness measure (visual analog scale). Both products were administered via three weekly injections, with follow-up evaluations at weeks 3, 6 and 12. Acetaminophen was permitted as rescue medication and quantitated by pill counts.

RESULTS

Analyses were performed on the intent-to-treat population, defined as all patients receiving at least one injection. Of the 321 patients randomized to treatment, 314 patients (98%) completed the final study assessment. Improvement in the average WOMAC Index pain score was 29.8mm (-61.6%) for Bio-HA and 28.8mm (-54.9%) for CL-HA, meeting the prospective criteria for non-inferiority. For the secondary outcome measures, statistically significant differences favored Bio-HA for the number of patients requiring acetaminophen (P=0.013) and patient global satisfaction evaluations (P=0.03). Local reactions differed between the products in that 15 effusions were reported in 13 CL-HA patients (8.1%) after injection, compared to one effusion (0.6%) after Bio-HA injection (P=0.0015).

CONCLUSION

The effectiveness of Bio-HA was not inferior to that of CL-HA. The significantly higher incidence of post-injection effusion in the CL-HA group provides a safety advantage for Bio-HA. These data suggest that Bio-HA has an improved benefit-risk profile compared with CL-HA.

Authors+Show Affiliations

NOVA-CLINIC, Eichendorffweg 5, Biberach, Germany.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16242361

Citation

Kirchner, M, and D Marshall. "A Double-blind Randomized Controlled Trial Comparing Alternate Forms of High Molecular Weight Hyaluronan for the Treatment of Osteoarthritis of the Knee." Osteoarthritis and Cartilage, vol. 14, no. 2, 2006, pp. 154-62.
Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthr Cartil. 2006;14(2):154-62.
Kirchner, M., & Marshall, D. (2006). A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis and Cartilage, 14(2), 154-62.
Kirchner M, Marshall D. A Double-blind Randomized Controlled Trial Comparing Alternate Forms of High Molecular Weight Hyaluronan for the Treatment of Osteoarthritis of the Knee. Osteoarthr Cartil. 2006;14(2):154-62. PubMed PMID: 16242361.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. AU - Kirchner,M, AU - Marshall,D, Y1 - 2005/10/19/ PY - 2005/03/11/received PY - 2005/09/06/accepted PY - 2005/10/26/pubmed PY - 2006/6/30/medline PY - 2005/10/26/entrez SP - 154 EP - 62 JF - Osteoarthritis and cartilage JO - Osteoarthr. Cartil. VL - 14 IS - 2 N2 - OBJECTIVE: To compare the safety and effectiveness of a high molecular weight hyaluronan produced by biological fermentation (Bio-HA) with those of avian-derived hyaluronan that uses cross-linking to achieve high molecular weight (CL-HA). DESIGN: This was a prospective, multicenter, randomized, double-blind trial evaluating patients with confirmed osteoarthritis of the knee. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Index) pain subscale was the primary effectiveness measure (visual analog scale). Both products were administered via three weekly injections, with follow-up evaluations at weeks 3, 6 and 12. Acetaminophen was permitted as rescue medication and quantitated by pill counts. RESULTS: Analyses were performed on the intent-to-treat population, defined as all patients receiving at least one injection. Of the 321 patients randomized to treatment, 314 patients (98%) completed the final study assessment. Improvement in the average WOMAC Index pain score was 29.8mm (-61.6%) for Bio-HA and 28.8mm (-54.9%) for CL-HA, meeting the prospective criteria for non-inferiority. For the secondary outcome measures, statistically significant differences favored Bio-HA for the number of patients requiring acetaminophen (P=0.013) and patient global satisfaction evaluations (P=0.03). Local reactions differed between the products in that 15 effusions were reported in 13 CL-HA patients (8.1%) after injection, compared to one effusion (0.6%) after Bio-HA injection (P=0.0015). CONCLUSION: The effectiveness of Bio-HA was not inferior to that of CL-HA. The significantly higher incidence of post-injection effusion in the CL-HA group provides a safety advantage for Bio-HA. These data suggest that Bio-HA has an improved benefit-risk profile compared with CL-HA. SN - 1063-4584 UR - https://www.unboundmedicine.com/medline/citation/16242361/A_double_blind_randomized_controlled_trial_comparing_alternate_forms_of_high_molecular_weight_hyaluronan_for_the_treatment_of_osteoarthritis_of_the_knee_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1063-4584(05)00256-6 DB - PRIME DP - Unbound Medicine ER -