Durolane Versus Methylprednisolone in Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Durolane is a device, methylprednisolone in a drug
- Registration Number
- NCT01209364
- Lead Sponsor
- Galderma R&D
- Brief Summary
The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
- Subject (female or male) 35-80 years of age
- Unilateral knee pain
- Radiographic evidence of OA
- WOMAC pain score of 7-17
- Subject normally active
- Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
- Subject cooperative and able to communicate effectively with the investigators;
- Body mass index ≤ 40 kg/m2;
- Signed informed consent obtained.
- Knee effusion
- Contralateral knee OA
- Clinically significant joint pain from joints other than the knee
- Previous intra-articular steroid injection into the study knee within the last 3 months;
- Previous intra-articular HA injection into the study knee within the last 9 months;
- Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
- Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
- Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
- Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- Change in physical therapy for the knee within the last three months
- Arthroscopy or other surgical procedure in the study knee within the past 12 months;
- Any planned arthroscopy or other surgical procedure during the study period;
- Previous history or presence of active septic arthritis
- Active skin disease or infection in the area of the injection site;
- Systemic active inflammatory condition or infection
- Bleeding diathesis or use of anticoagulants
- Current uncontrolled diabetes mellitus;
- Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
- Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
- Involvement in other clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methylprednisolone Durolane is a device, methylprednisolone in a drug intraarticular injection Durolane Durolane is a device, methylprednisolone in a drug intraarticular hyaluronic acid
- Primary Outcome Measures
Name Time Method Pain level and responder rate up to 12 weeks
- Secondary Outcome Measures
Name Time Method WOMAC stiffness score 26 weeks blinded phase + 26 weeks OLE Will be assessed at each clinic visit
WOMAC physical function 26 weeks blinded phase + 26 weeks OLE Will be assessed at each clinic visit
Functional assessment 26 weeks blinded phase + 26 weeks OLE Will be assessed at each clinic visit
Safety assessment (Adverse Events) 26 weeks blinded phase + 26 weeks OLE Will be assessed at each clinic visit using standard questions
Trial Locations
- Locations (22)
Nexus Clinical Research
🇨🇦St John´s, Newfoundland and Labrador, Canada
Centre de Rhumatologie St-Louis
🇨🇦Saint-Foy, Quebec, Canada
Alberta Bone & Joint Health Institute
🇨🇦Calgary, Alberta, Canada
Orthopaedic & Sport Medicine Institute of Nova Scotia
🇨🇦Halifax, Nova Scotia, Canada
QEII Health Sciences Centre-New Halifax Infirmary
🇨🇦Halifax, Ontario, Canada
Dr. Wilson
🇨🇦Lunenburg, Nova Scotia, Canada
Fowler Kennedy Sport Medicine Clinic
🇨🇦London, Ontario, Canada
Charlton Medical Centre
🇨🇦Hamilton, Ontario, Canada
MAC Research Inc.
🇨🇦Hamilton, Ontario, Canada
Credit Valley Rheumatology
🇨🇦Mississauga, Ontario, Canada
The Arthritis Program Research Group
🇨🇦Newmarket, Ontario, Canada
Dr. Dobson
🇨🇦Peterborough, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Sport C.A.R.E. Women's College Hospital
🇨🇦Toronto, Ontario, Canada
Saskatoon Osteoporosis Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Läkargruppen Kristinelund
🇸🇪Göteborg, Sweden
Ortopediska huset
🇸🇪Stockholm, Sweden
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
🇬🇧Oswestry, United Kingdom
Kings College Hospital - Department of Rheumatology
🇬🇧London, United Kingdom
Läkarhuset Ellenbogen
🇸🇪Malmö, Sweden
Southampton General Hospital - MRC Epidemiology Resource Center
🇬🇧Southampton, United Kingdom