Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
1 other identifier
interventional
332
1 country
21
Brief Summary
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jun 2014
Typical duration for not_applicable knee-osteoarthritis
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 5, 2015
October 1, 2015
1.7 years
June 29, 2014
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
26 weeks
Secondary Outcomes (1)
Patient Global Assessment
26 weeks
Study Arms (2)
HYMOVIS
EXPERIMENTALHYADD(TM) 4 Hydrogel Intra-Articular Injection
Placebo
PLACEBO COMPARATORSaline Intra-Articular Injection
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic osteoarthritis of the knee.
You may not qualify if:
- No disorders which could interfere with study required assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Alabama Clinical Therapeutics
Brimingham, Alabama, 35235, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Med Center
Carmichael, California, 95608, United States
Triwest Research Associates
El Cajon, California, 92020, United States
Westlake Medical
Thousand Oaks, California, 91360, United States
Colorado Orthopedic Consultants
Englewood, Colorado, 80110, United States
Chase Medical
Waterbury, Connecticut, 06708, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Ormond Medical Arts
Ormond Beach, Florida, 32174, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Great Lakes Research Group
Bay City, Michigan, 48706, United States
Healthcare Research Network
Hazelwood, Missouri, 63042, United States
Fabio Orozco
Egg Harbor, New Jersey, 08234, United States
PMG Research of Raleigh
Raleigh, North Carolina, 27609, United States
New Horizons
Cincinnati, Ohio, 45242, United States
Columbus Clinical Research
Columbus, Ohio, 43213, United States
Blair Orphopedics
Altoona, Pennsylvania, 16602, United States
West Houston Clinical Research
Houston, Texas, 77055, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2014
First Posted
July 11, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
October 5, 2015
Record last verified: 2015-10