Abstract | OBJECTIVE: METHODS: A randomized, arthrocentesis-controlled, multicenter trial. Patients (n = 372) were randomized to 4 weekly HMW hyaluronan injections (O4, n = 128), 3 weekly HMW hyaluronan injections followed by one arthrocentesis (O3A1, n = 120), or 4 arthrocenteses without injection (control group, A4, n = 124). All patients had knee OA, as determined by Kellgren-Lawrence (K-L) grade, and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score > or = 200 mm and < 400 mm in index knee and < 150 mm in contralateral knee. The primary outcome measure was the proportion of patients achieving a 20% relative and 50 mm absolute improvement from baseline in WOMAC pain score at Weeks 8, 12, 16, and 22 post-baseline in the index knee. Secondary outcomes were Patient Global score, Investigator Global score, and Pain on Standing score. RESULTS: The evaluable subgroup consisted of patients with K-L grade 2 or 3 at baseline. The comparison of O4 versus A4 for the primary outcome approached, but did not reach, significance in the evaluable subgroup: 76% of O4 patients had > or = 20% improvement in WOMAC pain score at Week 8 compared to 62% of A4 patients. More O4 patients had > or = 40% improvement in WOMAC pain score compared to A4. The effectiveness of the 3-injection regimen (O3A1) was masked by a possible placebo effect from the needle injection procedure in the A4 (control) group. No differences between groups were observed with respect to incidence of adverse events. CONCLUSION: Our findings indicate that HMW hyaluronan is safe and seems to be effective in the treatment of mild to severe OA of the knee.
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Authors | David Neustadt, Jacques Caldwell, Mary Bell, John Wade, Joseph Gimbel |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 32
Issue 10
Pg. 1928-36
(Oct 2005)
ISSN: 0315-162X [Print] Canada |
PMID | 16206349
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antirheumatic Agents
- orthovisc
- Hyaluronic Acid
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Topics |
- Adult
- Antirheumatic Agents
(therapeutic use)
- Female
- Humans
- Hyaluronic Acid
(administration & dosage, analogs & derivatives, therapeutic use)
- Injections, Intra-Articular
- Male
- Middle Aged
- Osteoarthritis, Knee
(drug therapy, pathology, physiopathology)
- Pain
(drug therapy, physiopathology)
- Pain Measurement
- Severity of Illness Index
- Treatment Outcome
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