Hylan G-F 20 improves hip osteoarthritis: A prospective, randomized study

Physician and Sportsmedicine

Volumn 38, Issue 2, 2010, Pages 35-47

  Spitzer, Andrew I ^a   Bockow, Barry I ^b   Brander, Victoria A ^c   Yates, James W ^d   MacCarter, Daryl K ^e   Gudger, Garland K ^f   Haller, Stephanie ^g   Lake, Stephen L ^g   Magilavy, Daniel B ^g  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b Arthritis Northwest   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d Conway Medical Center ^*  (United States)

^e Idaho Arthritis and Osteoporosis Center   (United States)

^f Hughston Sports Medicine Foundation   (United States)

^g GENZYME CORPORATION   (United States)

Author keywords

Corticosteroid; Hip; Hyaluronan; Hylan G F 20; Methylprednisolone acetate; Osteoarthritis

Indexed keywords

ANTIRHEUMATIC AGENT; HYLAN G F 20; METHYLPREDNISOLONE ACETATE; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HIP OSTEOARTHRITIS; HOT FLUSH; HUMAN; HYPESTHESIA; INJECTION SITE DISCOMFORT; INJECTION SITE IRRITATION; JOINT STIFFNESS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE SPASM; PARESTHESIA; PATIENT ASSESSMENT; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SHAM PROCEDURE; INTRAARTICULAR DRUG ADMINISTRATION; KNEE OSTEOARTHRITIS; PAIN MEASUREMENT; TREATMENT OUTCOME;

DOUBLE-BLIND METHOD; HUMANS; INJECTIONS, INTRA-ARTICULAR; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN MEASUREMENT; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 77955371715     PISSN: 00913847     EISSN: None     Source Type: Journal    
DOI: 10.3810/psm.2010.06.1781     Document Type: Article

References (41)

1. Zhang W, Doherty M, Ardin N, et al; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005;64(5):669-681.
2. Srikanth VK, Fryer JL, Zhai G, Winzenberg TM, Hosmer D, Jones G. A meta-analysis of sex differences prevalence, incidence and severity of osteoarthritis. Osteoarthritis Cartilage. 2005;13(9):769-781. (Pubitemid 41263935)
3. Dawson I, Linsell L, Zondervan K, et al. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology. 2004;43(4):497-504. (Pubitemid 38489368)
4. Flanagan J, Casale FF, Thomas TL, Desai KB. Intra-articular injection for pain relief in patients awaiting hip replacement. Ann R Coll Surg Engl. 1988;70(3):156-157.
5. Plant MJ, Borg AA, Dziedzic K, Saklatvala J, Dawes PT. Radiographic patterns and response to corticosteroid hip injection. Ann Rheum Dis. 1997;56(8):476-480. (Pubitemid 27396034)
6. Robinson P, Keenan AM, Conaghan PG. Clinical effectiveness and dose response of image-guided intra-articular corticosteroid injection for hip osteoarthritis. Rheumatology. 2007;46(2):285-291. (Pubitemid 46189790)
7. Kullenberg B, Runesson R, Tuvhag R, Olsson C, Resch S. Intraarticular corticosteroid injection: pain relief in osteoarthritis of the hip? J Rheumatol. 2004;31(11):2265-2268.
8. Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP. Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2007;56(7):2278-2287.
9. Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-162.
10. Synvisc [package insert]. Ridgefield, NJ: Genzyme Biosurgery; 2006.
11. Brocq O, Tran G, Breuil V, Grisot C, Flory P, Euller-Ziegler L. Hip osteoarthritis: short-term efficacy and safety of viscosupplementation by hylan G-F 20. An open-label study in 22 patients. Joint Bone Spine. 2002;69:388-391.
12. Conrozier T, Bertin P, Mathieu P, et al. Intra-articular injection of hylan G-F 20 in patients with symptomatic hip osteoarthritis: an open-label, multicentre, pilot study. Clin Exp Rheumatol. 2003;21(5):605-610.
13. Tikiz C, Unlu, Z, Sener A, Efe M, Tüzün C. Comparison of the efficacy of lower and higher molecular weight viscosupplementation in the treatment of hip osteoarthritis. Clin Rheumatol. 2005;24(3):244-250.
14. Conrozier T, Bertin P, Bailleul F, et al. Clinical response to intra-articular injection of hylan G-F 20 in symptomatic hip osteoarthritis: the OMERACT-OARSI criteria applied to the results of a pilot study. Joint Bone Spine. 2006;73(6):705-709.
15. Koseoglu BF, Sutbeyaz ST, Sezer N, Hatipoglu C, Comert D. Efficacy and safety of ultrasound guided intra-articular injections of hylan G-F 20 in patients with hip osteoarthritis. Pain Clinic. 2005;17(4):395-400.
16. Migliore A, Tormenta S, Martin Martin LS, et al. The symptomatic effects of intra-articular administration of hylan G-F 20 on osteoarthritis of the hip: clinical data of 6 months follow-up. Clin Rheumatol. 2006;25(3):389-393.
17. Migliore A, Tormenta S, Massafra U, et al. 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. Curr Med Res Opin. 2008;24(5):1309-1316.
18. Caglar-Yagci H, Unsal S, Yagci I, Dulgeroglu D, Ozel S. Safety and efficacy of ultrasound-guided intra-articular hylan G-F 20 injection in osteoarthritis of the hip: a pilot study. Rheumatol Int. 2005;25:341-344.
19. Bragantini A, Molinaroli F. A pilot clinical evaluation of the treatment of hip osteoarthritis with hyaluronic acid. Curr Ther Res. 1994;55(3):319-330.
20. Berg P, Olsson U. Intra-articular injection of non-animal stabilised hyaluronic acid (NASHA) for osteoarthritis of the hip: a pilot study. Clin Exp Rheumatol. 2004;22(3):300-306.
21. Migliore A, Tormenta S, Massafra U, et al. Repeated ultrasound-guided intra-articular injections of 40 mg of Hyalgan may be useful in symptomatic relief of hip osteoarthritis. Osteoarthritis Cartilage. 2005;13(12):1126-1127.
22. Pourbagher MA, Ozalay M, Pourbagher A. Accuracy and outcome of sonographically guided intra-articular sodium hyaluronate injections in patients with osteoarthritis of the hip. J Ultrasound Med. 2005;24(10):1391-1395.
23. Conrozier T, Couris CM, Mathieu P, et al. Safety, efficacy and predictive factors of efficacy of a single intra-articular injection of non-animal- stabilized-hyaluronic-acid in the hip joint: results of a standardized follow-up of patients treated for hip osteoarthritis in daily practice. Arch Orthop Trauma Surg. 2009;129(6):843-848.
24. Qvistgaard E, Christensen R, Torp-Pedersen S, Bliddal H. Intra-articular treatment of hip osteoarthritis: a randomized trial of hyaluronic acid, corticosteroid, and isotonic saline. Osteoarthritis Cartilage. 2006;14(2):163-170.
25. Migliore A, Massafra U, Bizzi E, et al. Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix(R)) injections versus local anesthetic in osteoarthritis of the hip. Arthritis Res Ther. 2009;11(6):R183.
26. Richette P, Ravaud P, Conrozier T, et al. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009;60(3):824-830.
27. Altman R, Alarcón G, Appelrouth D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34(5):505-514.
28. Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16:494-502.
29. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833-1840.
30. Angst F, Ewert T, Lehmann S, Aeschlimann A, Stucki G. The factor subdimensions of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) help to specify hip and knee osteoarthritis. A prospective evaluation and validation study. J Rheumatol. 2005;32(7):1324-1330.
31. Siddiqui O, Hung HM, O'Neill R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat. 2009;19(2):227-246.
32. Mallinckrodt CH, Lane PW, Schnell D, Peng Y, Mancuso JP. Recommendations for the primary analysis of continuous endpoints in longitudinal clinical trials. Drug Information Journal. 2008;42:303-319.
33. Rubin DM. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley and Sons, Inc; 1987.
34. Pham T, Van Der Heijde D, Lassere M, et al; OMERACT-OARSI. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30(7):1648-1654.
35. Pham T, Van Der Heijde D, Altman RD, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004;12(5):389-399.
36. Moore RA, Derry S, McQuay HJ. Discontinuation rates in clinical trials in musculoskeletal pain: meta-analysis from etoricoxib clinical trial reports. Arthritis Res Ther. 2008;10(3):R53.
37. Vad VB, Sakalkale D, Sculco TP, Wickiewicz TL. Role of hylan G-F 20 in treatment of osteoarthritis of the hip joint. Arch Phys Med Rehabil. 2003;84(8):1224-1226.
38. Tubach F, Baron G, Falissard B, et al. Using patients' and rheumatologists' opinions to specify a short form of the WOMAC function subscale. Ann Rheum Dis. 2005;64(1):75-79.
39. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105-121.
40. Benito MJ, Veale DJ, FitzGerald O, van den Berg WB, Bresnihan B. Synovial tissue inflammation in early and late osteoarthritis. Ann Rheum Dis. 2005;64(9):1263-1267.
41. Waddell DD, Bricker DC. Total knee replacement delayed with hylan G-F 20 use in patients with grade IV osteoarthritis. J Manag Care Pharm. 2O07;13(2):113-121.