A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results

Raynauld, J. P., Torrance, G. W., Band, P. A., Goldsmith, C. H., Tugwell, P., Walker, V., Schultz, M. and Bellamy, N. (2002) A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results. Osteoarthritis And Cartilage, 10 7: 506-517. doi:10.1053/joca.2002.0798


Author Raynauld, J. P.
Torrance, G. W.
Band, P. A.
Goldsmith, C. H.
Tugwell, P.
Walker, V.
Schultz, M.
Bellamy, N.
Title A prospective, randomized, pragmatic, health outcomes trial evaluating the incorporation of hylan G-F 20 into the treatment paradigm for patients with knee osteoarthritis (Part 1 of 2): clinical results
Journal name Osteoarthritis And Cartilage   Check publisher's open access policy
ISSN 1063-4584
Publication date 2002-01-01
Sub-type Article (original research)
DOI 10.1053/joca.2002.0798
Open Access Status DOI
Volume 10
Issue 7
Start page 506
End page 517
Total pages 12
Editor R. D. Altman
M. C. Hochberg et al.
Place of publication Exeter, U.K.
Publisher Elsevier Science
Language eng
Subject C1
321028 Rheumatology and Arthritis
730306 Evaluation of health outcomes
Abstract Objective: First, to assess the clinical effectiveness of hylan G-F 20 in an appropriate care treatment regimen (as defined by the American College of Rheumatology (ACR) 1995 guidelines) as measured by validated disease-specific outcomes and health-related quality of life endpoints for patients with osteoarthritis (OA) of the knee. Second, to utilize the measures of effectiveness and costs in an economic evaluation (see accompanying manuscript). Design: A total of 255 patients with OA of the knee were enrolled by rheumatologists or orthopedic surgeons into a prospective, randomized, open-label, 1-year, multi-centred trial, conducted in Canada. Patients were randomized to 'Appropriate care with hylan G-F 20' (AC+H) or 'Appropriate care without hylan G-F 20' (AC). Data were collected at clinic visits (baseline, 12 months) and by telephone (1, 2, 4, 6, 8, 10, and 12 months). Results: The AC+H group was superior to the AC group for all primary (% reduction in mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale: 38% vs 13%, P=0.0001) and secondary effectiveness outcome measures. These differences were all statistically significant and exceeded the 20% difference between groups seta priori by the investigators as the minimum clinically important difference. Health-related quality of life improvements in the AC+H group were statistically superior for the WOMAC pain, stiffness and physical function (all P<0.0001), the SF-36 aggregate physical component (P<0.0001) and the Health Utilities Index Mark 3 (HUI3) overall health utility score (P<0.0001). Safety (adverse events and patient global assessments of side effects) differences favoured the AC+H group. Conclusion: The data presented here indicate that the provision to patients with knee OA of viscosupplementation with hylan G-F 20 within an appropriate care treatment regimen provides benefits in the knee, overall health and health related quality of life at reduced levels of co-therapy and systemic adverse reactions.
Keyword Orthopedics
Rheumatology
Hylan G-f 20
Osteoarthritis
Knee
economics
Health-related Quality Of Life
Randomized Controlled Trial
Guidelines
Management
Arthritis
cost and cost analysis
health-related quality of life
Hip
Q-Index Code C1
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Medicine Publications
 
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Created: Wed, 15 Aug 2007, 03:49:24 EST