Effectiveness and Safety of a Multicenter Extension and Retreatment Trial of Gel-200 in Patients with Knee Osteoarthritis

Cartilage

Volumn 3, Issue 4, 2012, Pages 297-304

  Strand, V ^a   Baraf, H S B ^b   Lavin, P T ^c   Lim, S ^d   Hosokawa, H ^d  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Center for Rheumatology and Bone Research   (United States)

^c Boston Biostatistics Research Foundation   (United States)

^d SEIKAGAKU CORPORATION   (Japan)

Author keywords

clinical trial; Gel 200; intra articular delivery; knee; osteoarthritis

Indexed keywords

CHONDROITIN SULFATE; GEL 200; GEL ONE; GLUCOSAMINE; HYALURONIC ACID; MINOCYCLINE; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE; PARACETAMOL; PHOSPHATE BUFFERED SALINE; UNCLASSIFIED DRUG;

ADULT; AGED; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HUMAN; JOINT EFFUSION; JOINT SWELLING; KNEE OSTEOARTHRITIS; MALE; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PAIN; PATIENT SAFETY; RANDOMIZED CONTROLLED TRIAL; RIGIDITY; SCORING SYSTEM; THERAPY EFFECT; TREATMENT RESPONSE;

EID: 84867091212     PISSN: 19476035     EISSN: 19476043     Source Type: Journal    
DOI: 10.1177/1947603512451024     Document Type: Article

References (22)

1. Buckwalter JA,Saltzman C,Brown T.The impact of osteoarthritis: implications for research.Clin Orthop Relat Res. 2004;427 (Suppl): S6-S15.
2. Bellamy N,Campbell J,Robinson V,Gee T,Bourne R,Wells G.Viscosupplementation for the treatment of osteoarthritis of the knee.Cochrane Database Syst Rev. 2006;2:CD005321.
3. Jordan KM,Arden NK,Doherty M,Bannwarth B,Bijlsma JWJ,Dieppe P, et al.EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT).Ann Rheum Dis. 2003;62:1145-55.
4. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update.Arthritis Rheum. 2000;43:1905-15.
5. Zhang W,Moskowitz RW,Nuki G,Abramson S,Altman RD,Arden N, et al.OARSI recommendations for the management of hip and knee osteoarthritis. Part II: OARSI evidence-based, expert consensus guidelines.Osteoarthritis Cartilage. 2008;16:137-62.
6. McAlindon TE,Bannuru RR.OARSI recommendations for the management of hip and knee osteoarthritis: the semantics of differences and changes.Osteoarthritis Cartilage. 2010;18:473-5.
7. Matsuda T,Moghaddam MJ,Miwa H,Sakurai K,Iida F.Photoinduced prevention of tissue adhesion.ASAIO J. 1992;38:M154-M1547.
8. Strand V,Baraf HSB,Lavin PT,Lim S,Hosokawa H.A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee.Osteoarthritis Cartilage. 2012;20:350-6.
9. Dougados M,Leclaire P,van der Heijde D,Bloch DA,Bellamy N,Altman RD.Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative.Osteoarthritis Cartilage. 2000;8:395-403.
10. Pham T,van der Heijde D,Lassare M,Altman RD,Anderson JJ,Bellamy N, et al.Outcome variables for osteoarthritis clinical trials: the OMERACT-OARSI set of responder criteria.J Rheumatol. 2003;30:1648-54.
11. Pham T,van der Heijde D,Altman RD,Anderson JJ,Bellamy N,Hochberg M, et al.OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.Osteoarthritis Cartilage. 2004;12:389-99.
12. Chevalier X,Jerosch J,Goupille P,Dijk NV,Luyten FP,Scott DL, et al.Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial.Ann Rheum Dis. 2010;69:113-9.
13. Altman RD,Rosen JE,Bloch DA,Hatoum HT,Korner P.A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial).Semin Arthritis Rheum. 2009;39:1-9.
14. Jüni P,Reichenbach S,Trelle S,Tschannen B,Wandel S,Jordi B, et al.Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: a randomized controlled trial.Arthritis Rheum. 2007;56:3610-9.
15. 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.Osteoarthritis Cartilage. 2006;14:154-62.
16. Leopold SS,Warme WJ,Pettis PD,Shott S.Increased frequency of acute local reaction to intra-articular hylan GF-20 (synvisc) in patients receiving more than one course of treatment.J Bone Joint Surg Am. 2002;84:1619-23.
17. Waddell DD,Cefalu CA,Bricker DC.An open-label study of a second course of hylan G-F 20 for the treatment of pain associated with knee osteoarthritis.Curr Med Res Opin. 2003;19:499-507.
18. Puttick MP,Wade JP,Chalmers A,Connell DG,Rangno KK.Acute local reactions after intraarticular hylan for osteoarthritis of the knee.J Rheumatol. 1995;22:1311-4.
19. Pullman-Mooar S,Mooar P,Sieck M,Clayburne G,Schumacher HR.Are there distinctive inflammatory flares after hylan g-f 20 intraarticular injections?.J Rheumatol. 2002;29:2611-4.
20. Goldberg VM,Coutts RD.Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment.Clin Orthop Relat Res. 2004;419:130-7.
21. Roos J,Epaulard O,Juvin R,Chen C,Pavese P,Brion JP.Acute pseudoseptic arthritis after intra-articular sodium hyaluronan.Joint Bone Spine. 2004;71:352-4.
22. Tahiri L,Benbouazza K,Amine B,Hajjaj-Hassouni N.Acute pseudoseptic arthritis after viscosupplementation of the knee: a case report.Clin Rheumatol. 2007;26:1977-9.