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Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

NCT ID: NCT01335321

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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So far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of OA. The viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. Today there are various papers on the treatment of gonarthrosis by intraarticular injection. Several methods have shown good results. There isn't, however, a consensus on the best method. The investigators know that in the treatment of osteoarthritis, with the viscosupplementation Hylan is superior in the long term, than the infiltration with cortisone. The good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. The investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. Patients in group 1 will be subjected to infiltration procedure 6ml of Hylan. Patients in Group 2 will undergo the procedure of infiltration with 6ml of Hylan and 1ml (20mg) of hexacetonide Triamcinolone. The researcher will apply the informed consent term, the pain visual analog scale (VAS), WOMAC and Lequesne questionnaires. The questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).

Conditions

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Osteoarthritis

Keywords

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viscosupplementation intra-articular injection hyaluronic acid osteoarthritis knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hylan GF-20 alone

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

Group Type ACTIVE_COMPARATOR

Hylan GF-20 alone

Intervention Type DRUG

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

Triamcinolone

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

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

Interventions

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Hylan GF-20 alone

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

Intervention Type DRUG

Triamcinolone

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

Intervention Type DRUG

Other Intervention Names

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Synvisc One Synvisc One and Triancil

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Development of Pioarthritis
* Failure to attend to the consultations
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marcia Uchoa Rezende

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olavo Pires de Camargo, Prof. Dr.

Role: STUDY_CHAIR

Faculdade de Medicina da Universidade de São Paulo

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 15703953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20048527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18430574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10768539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16083536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19950318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16625635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19304567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18365224 (View on PubMed)

Other Identifiers

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2010/11450-9

Identifier Type: -

Identifier Source: org_study_id