At a glance
ClinicalIndex Comparison RecordN/ACompleted· 814 enrolled
Drug / intervention
Gel-One +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Gel-One and PBS for Osteoarthritis Knee. Completed, enrolled 814 participants across 41 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis Knee
CountriesUnited States
CollaboratorsZimmer Biomet
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionMar 2016
TodayJul 2026
First PostedSep 4, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.8 years ago
Interventions
Gel-Onedevice
PBSdevice