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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synvisc group | Experimental | 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 |
|
| Osteoarthritis standard treatment group | Active Comparator | Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylan G-F 20 | Drug |
|
| |
| Standard treatment |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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)
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C049816 | hylan |
| D026741 | Physical Therapy Modalities |
| D006875 | Hydrotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Drug |
Standard drug treatment at the discretion of the investigator |
|
| Physiotherapy | Procedure |
|
| Hydrotherapy | Procedure |
|
| 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 |