Gel-One Treatment in Knee Osteoarthritis
A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension
1 other identifier
interventional
814
1 country
41
Brief Summary
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Typical duration for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 29, 2013
CompletedFirst Posted
Study publicly available on registry
September 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
July 2, 2017
CompletedMarch 23, 2023
March 1, 2023
2.6 years
August 29, 2013
February 1, 2017
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.
Baseline up to Week26
Study Arms (2)
Gel-One
ACTIVE COMPARATOR3 mL, a single intra-articular injection of Gel-One
Phosphate Buffered Saline (PBS)
PLACEBO COMPARATOR3 mL, a single intra-articular injection of PBS
Interventions
Eligibility Criteria
You may qualify if:
- Have a knee pain
- Grade 1 to 3 on the Kellgren-Lawrence grading scale
You may not qualify if:
- BMI greater than 35 kg/m2
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seikagaku Corporationlead
- Zimmer Biometcollaborator
Study Sites (41)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Sheffield, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Cerritos, California, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Garden Grove, California, United States
Unknown Facility
North Hollywood, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
Cos Cob, Connecticut, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Oviedo, Florida, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Sarasota, Florida, United States
Unknown Facility
Tamarac, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Morton Grove, Illinois, United States
Unknown Facility
Newton, Kansas, United States
Unknown Facility
Wichita, Kansas, United States
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Lake Charles, Louisiana, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
St Louis, Missouri, United States
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Trenton, New Jersey, United States
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Hartsdale, New York, United States
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New York, New York, United States
Unknown Facility
High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Altoona, Pennsylvania, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
State College, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Bedford, Texas, United States
Unknown Facility
Charlottesville, Virginia, United States
Related Publications (1)
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.
PMID: 29644875DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Dept.
- Organization
- Seikagaku Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 4, 2013
Study Start
August 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 23, 2023
Results First Posted
July 2, 2017
Record last verified: 2023-03