Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis
NCT ID: NCT01753830
Last Updated: 2022-08-26
Study Results
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View full resultsBasic Information
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TERMINATED
NA
75 participants
INTERVENTIONAL
2012-12-31
2014-02-28
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
DOUBLE
Study Groups
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Durolane
Single intraarticular injection of Durolane
Durolane
4.5 mL
PBS
Single intraarticular injection of PBS
PBS
4.5 mL
Interventions
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Durolane
4.5 mL
PBS
4.5 mL
Eligibility Criteria
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Inclusion Criteria
* Symptomatic osteoarthritis (OA) of the knee
* K L severity grade 1 or 2
* If bilateral OA, contralateral knee K L severity grade 0 or 1
Exclusion Criteria
* Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
* Has any painful orthopedic disorders of the back or hip
* Has a joint disorder other than osteoarthritis in the index knee
40 Years
80 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Nebojsa Skrepnik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tucson Orthopaedic Institute
Locations
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Anniston, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Beverly Hills, California, United States
El Cajon, California, United States
Boulder, Colorado, United States
Danbury, Connecticut, United States
Trumbull, Connecticut, United States
Lauderdale Lakes, Florida, United States
Pinellas Park, Florida, United States
South Miami, Florida, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Evansville, Indiana, United States
New Orleans, Louisiana, United States
Wheaton, Maryland, United States
Kalamazoo, Michigan, United States
Springfield, Missouri, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Norfolk, Virginia, United States
Countries
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Other Identifiers
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35GA1203
Identifier Type: -
Identifier Source: org_study_id
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