Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Start Date
4/26/2023
Completion Date
6/1/2027
Summary
The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.
Detailed Description
Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).
Eligibility Criteria
Age Range: 18 years to 40 years
Interventions
AM3101
Saline Placebo
Conditions
Locations
University of Cincinnati
Cincinnati, Ohio 45267
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Oregon Health & Science University
Portland, Oregon 97239
United States