Study Results
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View full resultsBasic Information
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COMPLETED
NA
814 participants
INTERVENTIONAL
2013-08-31
2016-03-31
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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Gel-One
3 mL, a single intra-articular injection of Gel-One
Gel-One
Phosphate Buffered Saline (PBS)
3 mL, a single intra-articular injection of PBS
PBS
Interventions
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Gel-One
PBS
Eligibility Criteria
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Inclusion Criteria
* Grade 1 to 3 on the Kellgren-Lawrence grading scale
Exclusion Criteria
* Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
* Had a joint replacement of the target knee
40 Years
80 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Seikagaku Corporation
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Sheffield, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Cerritos, California, United States
Costa Mesa, California, United States
Garden Grove, California, United States
North Hollywood, California, United States
San Diego, California, United States
Boulder, Colorado, United States
Englewood, Colorado, United States
Cos Cob, Connecticut, United States
Trumbull, Connecticut, United States
Oviedo, Florida, United States
Pinellas Park, Florida, United States
Plantation, Florida, United States
Sarasota, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Morton Grove, Illinois, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Lake Charles, Louisiana, United States
Wheaton, Maryland, United States
St Louis, Missouri, United States
Trenton, New Jersey, United States
Hartsdale, New York, United States
New York, New York, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
State College, Pennsylvania, United States
Austin, Texas, United States
Bedford, Texas, United States
Charlottesville, Virginia, United States
Countries
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References
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Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12.
Other Identifiers
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Gel/1133
Identifier Type: -
Identifier Source: org_study_id
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