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Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Meniscus Tear Clinical Trial

Official title:
A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05560477
Study type Interventional
Source University of Cincinnati
Contact Kimberly A Hasselfeld, MS
Phone 513-558-1933
Email hasselky@ucmail.uc.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date April 26, 2023
Completion date June 2024
View Details
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