Hip Viscosupplementation: What is the Best Dosage?

Study Overview
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Brief Summary
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Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Detailed Description
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Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation

Official Title
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Hip Viscosupplementation: What is the Best Dosage?

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: articular lavage with saline injection
* Drug: 1 ampoule of Hylan GF-20
* Drug: 2 ampoules of Hylan GF-20
* Drug: 3 ampoules of Hylan GF-20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Met the American College of Rheumatology criteria for hip osteoarthritis No hip intraarticular injections in the last 6 months Exclusion Criteria: - Severe reaction to the procedure

Ages Eligible for Study
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Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Articular Lavage<br>Patients from Group Zero will receive articular lavage with saline injection | Procedure: articular lavage with saline injection<br>* Patients will receive articular lavage with saline injection<br>|
| Experimental: Group 1<br>Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20 | Procedure: articular lavage with saline injection<br>* Patients will receive articular lavage with saline injection<br>Drug: 1 ampoule of Hylan GF-20<br>* Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20<br>* Other names: 1 ampole of Synvisc Classic;|
| Experimental: Group 2<br>Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20 | Procedure: articular lavage with saline injection<br>* Patients will receive articular lavage with saline injection<br>Drug: 2 ampoules of Hylan GF-20<br>* Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20<br>* Other names: 2 ampoles of Synvisc Classic;|
| Experimental: Group 3<br>Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20 | Procedure: articular lavage with saline injection<br>* Patients will receive articular lavage with saline injection<br>Drug: 3 ampoules of Hylan GF-20<br>* Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20<br>* Other names: 3 ampoules of Synvisc Classic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | Pain and function assessment with WOMAC questionaire | 6 months | 
| VAS | Pain assessment with Visual Analogic Scale (VAS) | 6 months | 
| Lequesne | Pain and function assessment with Lequesne questionaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Osteoarthritis, Viscosupplementation, Clinical Trial