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

A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Hylan G-F 20; Drug: Standard treatment; Procedure: Physiotherapy; Procedure: Hydrotherapy

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Hylan G-F 20; Other Names: Synvisc®
Active Comparator: Osteoarthritis standard treatment group; Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product	Drug: Standard treatment; Standard drug treatment at the discretion of the investigator; Procedure: Physiotherapy; Procedure: Hydrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Index of severity	Day 1, 29, 91, 182 and 274

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient	Day 1, 91, 182 and 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
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
Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)	Day 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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 1998
• Primary Completion (Actual): February 1, 2000

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Protective Agents; Viscosupplements; Hylan
• Other Study ID Numbers: 1139.4