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NCT07748793
Autologous Fat Grafting for the Treatment of Chronic Tendinopathy
Conditions: Chronic Tendinopathy
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Weill Medical College of Cornell University
Location: Department of Rehabilitation Medicine WCMC New York New York
Summary
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
Inclusion Criteria
1. Age 18-80 years.
2. Tendinopathy at any tendon location (e.g., rotator cuff/supraspinatus, lateral epicondyle, gluteal/hip, Achilles, patellar).
3. Confirmed tendon pathology: pain at the tendon site for \> 3 months AND pathology confirmed on ultrasound.
4. Failure of conservative treatment (e.g., activity modification, physical therapy, NSAIDs, corticosteroid injection, and/or PRP) for at least 6 weeks.
5. Able to provide informed consent and complete questionnaires in English.
Exclusion Criteria
1. Full-thickness tendon tear.
2. Prior surgery at the target tendon site.
3. Injection or other intervention at the target tendon site within the prior 6 months.
4. Pregnancy or breastfeeding.
5. Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe.
6. Moderate-to-high-grade arthritis in the adjacent joint.
Source: ClinicalTrials.gov (NCT07748793). StuddyBuddy aggregates publicly available trial information.