Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military

PHASE2CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2024

Conditions
Tibial Meniscus InjuriesKnee InjuriesKnee Injuries and Disorders
Interventions
DEVICE

Lipogems

The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the meniscal lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.

DRUG

Normal Saline

"Normal Saline solution is a mixture of sodium chloride in water (9 g NaCl per liter water, 0.9% saline). Trephination allows for vascular growth and healing, especially in the inner avascular regions of the meniscus, by puncturing the meniscus. Small tunnels are created, which allow for healing factors to reach the avascular inner region of the meniscus from the vascular peripheral regions."

Trial Locations (1)

07052

Kessler Foundation, West Orange

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Walter Reed National Military Medical Center

FED

collaborator

Uniformed Services University of the Health Sciences

FED

lead

Kessler Foundation

OTHER

NCT04274543 - Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military | Biotech Hunter | Biotech Hunter