Durolane Versus Methylprednisolone in Knee Osteoarthritis
NCT ID: NCT01209364
Last Updated: 2022-08-25
Study Results
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Basic Information
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COMPLETED
PHASE3
442 participants
INTERVENTIONAL
2007-03-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Durolane
intraarticular hyaluronic acid
Durolane is a device, methylprednisolone in a drug
single intraarticular injection
methylprednisolone
intraarticular injection
Durolane is a device, methylprednisolone in a drug
single intraarticular injection
Interventions
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Durolane is a device, methylprednisolone in a drug
single intraarticular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
35 Years
80 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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Alberta Bone & Joint Health Institute
Calgary, Alberta, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, Canada
Orthopaedic & Sport Medicine Institute of Nova Scotia
Halifax, Nova Scotia, Canada
Dr. Wilson
Lunenburg, Nova Scotia, Canada
QEII Health Sciences Centre-New Halifax Infirmary
Halifax, Ontario, Canada
Charlton Medical Centre
Hamilton, Ontario, Canada
MAC Research Inc.
Hamilton, Ontario, Canada
Fowler Kennedy Sport Medicine Clinic
London, 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
Centre de Rhumatologie St-Louis
Saint-Foy, Quebec, Canada
Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, Canada
Läkargruppen Kristinelund
Gothenburg, , Sweden
Ortopediska huset
Johanneshov, , Sweden
Läkarhuset Ellenbogen
Malmo, , Sweden
Ortopediska huset
Stockholm, , Sweden
Kings College Hospital - Department of Rheumatology
London, , United Kingdom
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
Newcastle, , United Kingdom
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
Oswestry, , United Kingdom
Southampton General Hospital - MRC Epidemiology Resource Center
Southampton, , United Kingdom
Countries
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References
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Leighton R, Akermark C, Therrien R, Richardson JB, Andersson M, Todman MG, Arden NK; DUROLANE Study Group. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014 Jan;22(1):17-25. doi: 10.1016/j.joca.2013.10.009. Epub 2013 Nov 1.
Other Identifiers
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35GA0608
Identifier Type: -
Identifier Source: org_study_id
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