Osteoarthritis
Conditions
Brief summary
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.
Interventions
DRUGHylan G-F 20
DRUGStandard treatment
Standard drug treatment at the discretion of the investigator
PROCEDUREPhysiotherapy
PROCEDUREHydrotherapy
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1, 29, 91, 182 and 274 | Index of severity |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient | Day 1, 91, 182 and 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 |
| Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS) | Day 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 |
Outcome results
None listed