Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

NCT01335321 | Completed Phase 4 DMC

• 1 other identifier: 2010/11450-9
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

Conditions

Osteoarthritis

Keywords

viscosupplementation; intra-articular injection; hyaluronic acid; osteoarthritis; knee

Outcome Measures

Primary Outcomes (1)

• Results in WOMAC, Lequesne and VAS scores

  The outcome will be measured with the WOMAC and LEQUESNE scores, both about quality of life and knee function. The subjects will also use the VAS (VISUAL ANALOGIC SCALE) of pain. The results will be compared between the two groups within 1 week and 4 weeks after the viscosupplementation.

  4 weeks

Secondary Outcomes (1)

• Results in WOMAC, Lequesne and VAS scores after 24 weeks

  24 weeks

Study Arms (2)

Hylan GF-20 alone

ACTIVE COMPARATOR

This arm will receive a knee infiltration with 6ml of Hylan GF-20 only

Drug: Hylan GF-20 alone

Triamcinolone

EXPERIMENTAL

This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone

Drug: Triamcinolone

Interventions

Hylan GF-20 alone DRUG

A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)

Also known as: Synvisc One

Hylan GF-20 alone

Triamcinolone DRUG

A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)

Also known as: Synvisc One and Triancil

Triamcinolone

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 45 and 80 years
• Osteoarthritis Diagnosis with radiographic evidence
• absence of previous intraarticular knee fracture
• absence of allergy to Synvisc or Triancil

You may not qualify if:

• Development of Pioarthritis
• Failure to attend to the consultations

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (9)

• Ozturk C, Atamaz F, Hepguler S, Argin M, Arkun R. The safety and efficacy of intraarticular hyaluronan with/without corticosteroid in knee osteoarthritis: 1-year, single-blind, randomized study. Rheumatol Int. 2006 Feb;26(4):314-9. doi: 10.1007/s00296-005-0584-z. Epub 2005 Feb 10.

  PMID: 15703953 BACKGROUND

• Brander VA, Stadler TS. Functional improvement with hylan G-F 20 in patients with knee osteoarthritis. Phys Sportsmed. 2009 Oct;37(3):38-48. doi: 10.3810/psm.2009.10.1728.

  PMID: 20048527 BACKGROUND

• Raman R, Dutta A, Day N, Sharma HK, Shaw CJ, Johnson GV. Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial. Knee. 2008 Aug;15(4):318-24. doi: 10.1016/j.knee.2008.02.012. Epub 2008 Apr 21.

  PMID: 18430574 BACKGROUND

• Goorman SD, Watanabe TK, Miller EH, Perry C. Functional outcome in knee osteoarthritis after treatment with hylan G-F 20: a prospective study. Arch Phys Med Rehabil. 2000 Apr;81(4):479-83. doi: 10.1053/mr.2000.4432.

  PMID: 10768539 BACKGROUND

• Kemper F, Gebhardt U, Meng T, Murray C. Tolerability and short-term effectiveness of hylan G-F 20 in 4253 patients with osteoarthritis of the knee in clinical practice. Curr Med Res Opin. 2005 Aug;21(8):1261-9. doi: 10.1185/030079905X56501.

  PMID: 16083536 BACKGROUND

• Bannuru RR, Natov NS, Obadan IE, Price LL, Schmid CH, McAlindon TE. Therapeutic trajectory of hyaluronic acid versus corticosteroids in the treatment of knee osteoarthritis: a systematic review and meta-analysis. Arthritis Rheum. 2009 Dec 15;61(12):1704-11. doi: 10.1002/art.24925.

  PMID: 19950318 BACKGROUND

• 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 Apr 19;2006(2):CD005321. doi: 10.1002/14651858.CD005321.pub2.

  PMID: 16625635 BACKGROUND

• Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. 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 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.

  PMID: 19304567 BACKGROUND

• Conrozier T, Jerosch J, Beks P, Kemper F, Euller-Ziegler L, Bailleul F, Chevalier X. Prospective, multi-centre, randomised evaluation of the safety and efficacy of five dosing regimens of viscosupplementation with hylan G-F 20 in patients with symptomatic tibio-femoral osteoarthritis: a pilot study. Arch Orthop Trauma Surg. 2009 Mar;129(3):417-23. doi: 10.1007/s00402-008-0601-2. Epub 2008 Mar 26.

  PMID: 18365224 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

hylan; Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Olavo Pires de Camargo, Prof. Dr.

  Faculdade de Medicina da Universidade de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: December 23, 2014

Record last verified: 2011-03

Locations

BR (1)