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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Hyaluronic Acid; Hylan

Criteria

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)