Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWeill Medical College of Cornell University

About this trial

The goal of this clinical trial is to learn whether a one-time injection of a person's own concentrated fat (micro-fragmented adipose tissue, or MFAT) can reduce pain and improve function in adults (ages 18-80) with chronic tendinopathy - tendon pain lasting more than 3 months (for example, in the shoulder, elbow, hip, knee, or Achilles) - that has not improved with usual treatments such as physical therapy, cortisone shots, or platelet-rich plasma.

The main questions it aims to answer are:

* Does injecting a person's own concentrated fat into a painful tendon reduce tendon pain? * Does it improve how well the tendon works, how long does any improvement last, and is the procedure safe?

This is a single-group study, so there is no separate comparison group; each participant's pain, function, and ultrasound results after treatment are compared with their own measurements taken before treatment.

Participants will:

* Have a one-time procedure in which a small amount of fat is removed from the abdomen by liposuction (under local numbing), concentrated, and injected into the painful tendon using ultrasound guidance. * Complete short pain and function questionnaires and have ultrasound imaging of the tendon at study visits. * Be followed for about 12 months, with a phone or video check-in 3-7 days after the procedure, a 2-week skin check of the fat-removal site, and visits at 6 weeks, 3 months, 6 months, and 12 months.

Eligibility criteria

Qualifiers

Age 18-80 years.

Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar).

Confirmed tendon pathology: pain at the tendon site for > 3 months AND pathology confirmed on ultrasound.

Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks.

Disqualifiers

Full-thickness tendon tear.

Prior surgery at the target tendon site.

Injection or other intervention at the target tendon site within the prior 6 months.

Pregnancy or breastfeeding.

Trial design

Treatments tested in this trial

  • Micro-Fragmented Adipose Tissue (MFAT) injection

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

The Plastic Surgery Foundation

Collaborator