Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Sinovial® (syringe containing sodium hyaluronate solution); Device: Synvisc® ( syringe containing Hylan G-F 20 solution)

• Registration Number: NCT00556608
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2009-07
• Study Completion: 2010-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

Inclusion Criteria

• Age between 40 and 80 years
• Primary knee OA of the medial or lateral femoro-tibial compartment
• Symptoms for at least 3 months
• Diagnosis according to ACR criteria
• Kellgren & Lawrence radiological grade 2-3
• Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
• Mean WOMAC pain subscore at the target knee >= 40 mm and < 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee < 30 mm
• Written informed consent
• Subject able to understand, co-operative and reliable

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Exclusion Criteria

• BMI >= 32 kg/m2
• Secondary (post-traumatic) knee OA
• Predominantly patello-femoral pain/syndrome
• No remaining joint space width
• Symptomatic hip OA or other interfering health condition
• Severe varus/valgus deformity (>15°)
• History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
• Concomitant rheumatic disease
• Significant injury to the target knee in the last 6 months
• Previous joint replacement/arthroplasty (target knee)
• Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
• Any surgery scheduled in the next 6 months
• Venous or lymphatic stasis in the relevant limb
• Skin infection/disease/trauma at the injection site
• Systemic or i.a. (target knee) corticosteroids in the past 3 months
• I.a. corticosteroids (non-target joint) in the past 4 weeks
• Viscosupplementation (target knee) in the past year
• Recently started (in the last 3 months) physical therapy (target knee)
• Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
• Ongoing anticoagulant therapy
• Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
• History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
• Participation in a clinical study in the last 3 months
• Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
• Patients unable to stay in the study for 6 months, non-cooperating, not able to understand

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinovial	Sinovial® (syringe containing sodium hyaluronate solution)	3 intra-articular injections of Sinovial®
Sinvisc	Synvisc® ( syringe containing Hylan G-F 20 solution)	-

Primary Outcome Measures

Name	Time	Method
Improvement in WOMAC pain subscore from baseline	to week 26

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%	26 weeks

Trial Locations

Locations (20)

Centrum léčby pohybového aparátu spol. s.r.o.; 🇨🇿 Praha, Czech Republic

University Hospital Centre Bois-Guillaume; 🇫🇷 Bois Guillaume, France

Medicina e Traumatologia dello Sport - AzUSL 2 Lucca; 🇮🇹 Lucca, Italy

ARTHROMED s.r.o.; 🇨🇿 Pardubice, Czech Republic

University Hospital Centre of Limoges - Rheumatology Service; 🇫🇷 Limoges Cedex, France

Interni hemato-onkologická klinika, Fakultní nemocnice; 🇨🇿 Brno - Bohunice, Czech Republic

Orthopädische Universitätsklinik und Poliklinik der RWTH Aachen; 🇩🇪 Aachen, Germany

Sezione Dipartimentale a valenza provinciale di Reumatologia - AzUSL 8; 🇮🇹 Arezzo, Italy

Ospedale Privato Accreditato Nigrisoli; 🇮🇹 Bologna, Italy

Orthopädische Praxis; 🇩🇪 Stockach, Germany

Institute of Rheumatology; 🇨🇿 Praha, Czech Republic

Nova clinic; 🇩🇪 Biberach an der Riss, Germany

National Institute of Rheumatic Diseases; 🇸🇰 Piest'any, Slovakia

Unità Operativa di Reumatologia - Istituto Ortopedico Gaetano Pini; 🇮🇹 Milano, Italy

F.D. Roosevelt's University Hospital; 🇸🇰 Banská Bystrica, Slovakia

Unità Operativa di Reumatologia - Az. Ospedaliera Universitaria Senese - Policlinico "Le Scotte"; 🇮🇹 Siena, Italy

Rheumatology Unit Santa Chiara Hospital; 🇮🇹 Pisa, Italy

Romjan s.r.o.; 🇸🇰 Bratislava, Slovakia

Department of Rheumatology and Institute of Physical Medicine - Zurich University; 🇨🇭 Zürich, Switzerland

Rheumatology Clinic, Reumaglobal s.r.o; 🇸🇰 Trnava, Slovakia