At a glance
ClinicalIndex Comparison RecordN/ACompleted· 251 enrolled
Drug / intervention
Agili-C implant +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 Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee
In Brief
A clinical study evaluating Agili-C implant and SSOC for Cartilage or Osteochondral Defects in the Knee and Up to Moderate Osteoarthritis. Completed, enrolled 251 participants across 26 sites in 8 countries.
Detailed Summary
The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Hungary, Israel, Italy, Poland, Romania, Serbia, United States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedOct 2017
Primary CompletionNov 2024
TodayJul 2026
First PostedOct 3, 2017
Enrollment StartSep 25, 2017
Primary CompletionNov 14, 2024
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 8.7 years ago
Interventions
Agili-C implantdevice
Agili-C implant
SSOCprocedure
microfracture and/or debridement