Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT05875480 - The Effectiveness of Telerehabilitation After Arthroscopic Meniscus Repair N/A
Terminated NCT01256788 - Post-op Treatment With Hyaluronic Acid Injections N/A
Not yet recruiting NCT06048341 - FNB in Meniscal Tear Under SA N/A
Not yet recruiting NCT06045884 - FNB in Meniscal Tear Under GA N/A
Completed NCT04956393 - The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study N/A
Completed NCT06227078 - Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears N/A
Recruiting NCT05882591 - Posteromedial Tibiofemoral Incongruence (PMTFI) Treatment N/A
Recruiting NCT05322005 - Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides N/A
Completed NCT02100059 - Motor and Sensory Deficits Following Partial Meniscectomy N/A
Completed NCT05370937 - Clınıcal Results of Evelator and Free Knot Methods In Medial Menıscus Posterior Root Tears N/A
Completed NCT01931735 - Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears N/A
Completed NCT02237001 - Study of Suture Repair of Torn Meniscus in the Knee N/A
Active, not recruiting NCT04361487 - Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
Completed NCT06409715 - Addressing Kinesiophobia in Post-Meniscoplasty Patients Through Progressive Muscle Relaxation Training and Acupressure N/A
Enrolling by invitation NCT04641351 - Corticosteroid Meniscectomy Randomized Trial Phase 4
Recruiting NCT05909865 - PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment N/A
Enrolling by invitation NCT03037242 - Outcomes of Meniscus Root Repair Using a Transtibial Pullout Technique N/A
Recruiting NCT05799196 - The Effectiveness of the Microfracture Technique in the Meniscal Healing
Recruiting NCT05261360 - Clinical Efficacy of Exosome in Degenerative Meniscal Injury Phase 2
Completed NCT05020938 - Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear