Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation
Recruitment status was Recruiting
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Purpose
The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Hylan GF-20 alone Drug: Triamcinolone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective And Randomized Study Evaluating Tthe Effect Of The Association Of Triamcinolone To The Viscosupplementation Of The Knee |
- Results in WOMAC, Lequesne and VAS scores [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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.
- Results in WOMAC, Lequesne and VAS scores after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]The investigators are also going to compare the results after 24 weeks
| Estimated Enrollment: | 108 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Hylan GF-20 alone
This arm will receive a knee infiltration with 6ml of Hylan GF-20 only
|
Drug: Hylan GF-20 alone
A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)
|
|
Experimental: Triamcinolone
This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone
|
Drug: Triamcinolone
A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Gustavo Constantino de Campos | +551182944304 | gustavoccampos@terra.com.br |
| Contact: Marcia Uchôa de Rezende | +551181226282 | murezende@uol.com.br |
| Brazil | |
| Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo | Recruiting |
| São Paulo, Brazil, 05403-010 | |
| Contact: Gustavo Constantino de Campos +5511 82944304 gustavoccampos@terra.com.br | |
| Contact: Marcia Rezende +551181226282 murezende@uol.com.br | |
| Principal Investigator: Gustavo Constantino de Campos | |
| Sub-Investigator: Marcia Uchôa de Rezende | |
| Study Chair: | Olavo Pires de Camargo, Prof. Dr. | Faculdade de Medicina da Universidade de São Paulo |
More Information
Publications:
| Responsible Party: | Gustavo Constantino de Campos, Hospital das Clínicas da Universidade de São Paulo |
| ClinicalTrials.gov Identifier: | NCT01335321 History of Changes |
| Other Study ID Numbers: | 2010/11450-9 |
| Study First Received: | April 12, 2011 |
| Last Updated: | April 13, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo General Hospital:
|
viscosupplementation intra-articular injection hyaluronic acid osteoarthritis knee |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013