Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.

Official Title
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A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Hylan G-F 20
* Drug: Standard treatment
* Procedure: Physiotherapy
* Procedure: Hydrotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatient aged at least 18 years Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs Patient's informed written consent obtained in accordance with French legislation Exclusion Criteria: Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present: nocturnal disturbances due to knee pain morning stiffness over 45 minutes increase of knee pain more than 50% within the last week articular reddening articular heat Intra-articular administration of hyaluronic acid in the target knee within the previous year Intra-articular administration of hyaluronic acid in the target knee within the three previous months Any other intra-articular injection in the target knee within the last 6 months Any contraindication to intra-articular injections Present or past history of infected target knee joint Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year Planned knee surgery within the nine following month Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity Known hypersensitivity to avian products Presence of lymphatic or venous stasis Pregnancy or breastfeeding Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance Participation in another clinical trial during this study or during the previous month Previous participation in this trial Patient who requires help concerning shopping or house keeping Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synvisc group<br>injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments | Drug: Hylan G-F 20<br> <br> * Other names: Synvisc®;|
| Active Comparator: Osteoarthritis standard treatment group<br>Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product | Drug: Standard treatment<br>* Standard drug treatment at the discretion of the investigator<br>Procedure: Physiotherapy<br> <br> Procedure: Hydrotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of knee OA treatment including cost of side effect related to OA treatment |  | up to 274 days | 
| Area under the curve (AUC) Lequesne index | Index of severity | Day 1, 29, 91, 182 and 274 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient |  | Day 1, 91, 182 and 274 | 
| Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3 |  | Day 1, 91, 182 and 274 | 
| Disease activity assessment by patient and investigator on a VAS |  | Day 1, 29, 91, 182 and 274 | 
| Acute congestive OA flares assessed through a questionnaire |  | Day 1, 29, 91, 182 and 274 | 
| Assessment of state of health of the patients with a quality of life questionnaire (SF 12) |  | Day 1, 91, 182, 274 | 
| Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS) |  | Day 274 | 
| Final global assessment of tolerability by patient and investigator on a four-point VRS |  | Day 274 | 
| Incidence and intensity of adverse events |  | up to day 274 | 
| Number of withdrawals due to adverse event |  | up to day 274 |