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

NCT ID: NCT02197026

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synvisc group

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

Group Type: EXPERIMENTAL

Hylan G-F 20

Intervention Type: DRUG

Osteoarthritis standard treatment group

Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: DRUG

Standard drug treatment at the discretion of the investigator

Physiotherapy

Intervention Type: PROCEDURE

Hydrotherapy

Intervention Type: PROCEDURE

Interventions

Hylan G-F 20

Intervention Type: DRUG

Standard treatment

Standard drug treatment at the discretion of the investigator

Intervention Type: DRUG

Physiotherapy

Intervention Type: PROCEDURE

Hydrotherapy

Intervention Type: PROCEDURE

Other Intervention Names

Synvisc®

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1139.4

Identifier Type: -

Identifier Source: org_study_id