The purpose of this research study is to determine the safety and effectiveness of two different treatments, micro-fragmented adipose tissue (MFAT) and saline injection, for the treatment of meniscal tears. Participants are randomly assigned to one of these two treatment groups.
Micro-fragmented adipose tissue injection is a treatment technique that uses a person's fat tissue to fill joint, muscle, ligament, and/or cartilage defects, like those associated with meniscal tears. Fat is harvested from the abdomen and then prepared using a special device. The fat is then injected into your knee using ultrasound guidance.
The goal of MFAT and saline injections is stimulation of tissue healing to reduce knee pain and dysfunction.
Participation lasts for approximately 12 months and involves up to 7 visits. The initial screening and treatment visits take approximately 2-3 hours. The remaining follow-up visits will be done either over the phone, online, or in the clinic and could take up to 1 hour. The clinic is located at the New Jersey Regenerative Institute in Parsippany, NJ.
- Individuals who are 18-45 years of age
- have at least one of the following symptoms in a knee: clicking, popping, giving way, pain with pivoting or twisting, and/or pain that occurs occasionally or irregularly
- have pain that can occur when the knee joint line is manipulated or compressed
- have pain on the outside of the knee that has persisted for a least 4 weeks despite conservative treatments, which has included anti-inflammatory or other medications for pain; physical therapy, or injections that include corticosteroids and/or hyaluronic acid
- knee pain during activity is at least a 4 out of 10 (where 0 is "no pain" and 10 is "worst pain imaginable).
- have MRI or arthroscopic evidence of a meniscal tear
- You would also qualify if you have been told by an orthopedic surgeon that you would be a candidate for arthroscopic partial meniscectomy.
There is no compensation for participating in this study.
R-1065-19
