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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Procedure: Hydrotherapy; Procedure: Physiotherapy; Drug: Standard treatment; Drug: Hylan G-F 20

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197026

1139.4

Details and patient eligibility

About

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.

Enrollment: 518 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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518 participants in 2 patient groups

Synvisc group

Experimental group

Description:

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

Treatment:

Drug: Hylan G-F 20

Osteoarthritis standard treatment group

Active Comparator group

Description:

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

Treatment:

Procedure: Hydrotherapy

Drug: Standard treatment

Procedure: Physiotherapy