Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

Study Overview
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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).

Official Title
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Prospective And Randomized Study Evaluating Tthe Effect Of The Association Of Triamcinolone To The Viscosupplementation Of The Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Hylan GF-20 alone
* Drug: Triamcinolone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hylan GF-20 alone<br>This arm will receive a knee infiltration with 6ml of Hylan GF-20 only | Drug: Hylan GF-20 alone<br>* A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)<br>* Other names: Synvisc One;|
| Experimental: Triamcinolone<br>This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone | Drug: Triamcinolone<br>* A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)<br>* Other names: Synvisc One and Triancil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results in WOMAC, Lequesne and VAS scores after 24 weeks | The investigators are also going to compare the results after 24 weeks | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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viscosupplementation, intra-articular injection, hyaluronic acid, osteoarthritis, knee