Status:
COMPLETED
Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT02197026
Start Date
October 1 1998
Last Update
July 22 2014
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