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Clinical Trials/NCT07748793
NCT07748793Not yet recruitingNot Applicable

Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

Weill Medical College of Cornell University1 site in 1 country40 target enrollmentStarted: August 1, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.
  • •Able to provide informed consent and complete questionnaires in English.

Exclusion Criteria

  • •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.
  • •Active local or systemic infection, bleeding diathesis or anticoagulation precluding the procedure, or other condition that in the investigator's judgment makes participation unsafe.
  • •Moderate-to-high-grade arthritis in the adjacent joint.

Arms & Interventions

Micro-Fragmented Adipose Tissue (MFAT) Injection

Experimental

All participants receive a single, one-time autologous fat grafting procedure (no comparison group). A small volume of abdominal fat (5-15 cc) is harvested by manual liposuction under local anesthesia and concentrated by gentle manual rolling on non-adherent (Telfa) dressings to create micro-fragmented adipose tissue (MFAT). Under ultrasound guidance, the target tendon undergoes percutaneous tenotomy (needle fenestration) to disrupt scar tissue, followed by intratendinous injection of 1-3 cc of concentrated MFAT. Participants are then followed for 12 months with patient-reported pain and function questionnaires and ultrasound imaging. This is a single-arm, open-label study in which each participant serves as their own baseline control.

Intervention: Micro-Fragmented Adipose Tissue (MFAT) injection (Procedure)

Outcomes

Primary Outcomes

Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months

Time Frame: Baseline (pre-procedure) and Month 6

Pain in the affected tendon is self-reported on the 11-point Numeric Rating Scale (NRS), an integer from 0 to 10 where 0 = no pain and 10 = worst pain imaginable. The outcome is the mean change from baseline (pre-procedure) to Month 6, calculated as the Month 6 score minus the baseline score. A negative change indicates improvement; a lower score is a better outcome.

Secondary Outcomes

  • Change From Baseline in Patient-Reported Pain (NRS) at Week 6(Baseline, Week 6)
  • Change From Baseline in Patient-Reported Pain (NRS) at Month 3(Baseline, Month 3)
  • Change From Baseline in Patient-Reported Pain (NRS) at Month 12(Baseline, Month 12)
  • Mean Change From Baseline in LEFS at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in LEFS at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in LEFS at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in LEFS at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in HOOS Pain Subscale at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in HOOS Pain Subscale at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in HOOS Pain Subscale at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in HOOS Pain Subscale at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in HOOS Symptoms Subscale at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in HOOS Symptoms Subscale at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in HOOS Symptoms Subscale at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in HOOS Symptoms Subscale at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in HOOS Sport/Recreation Subscale at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in HOOS Quality of Life Subscale at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in HOOS Quality of Life Subscale at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in HOOS Quality of Life Subscale at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in HOOS Quality of Life Subscale at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in DASH at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in DASH at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in DASH at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in DASH at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in MEPI at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in MEPI at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in MEPI at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in MEPI at Month 12(Baseline - Month 12)
  • Mean Change From Baseline in VISA-A at Week 6(Baseline - Week 6)
  • Mean Change From Baseline in VISA-A at Month 3(Baseline - Month 3)
  • Mean Change From Baseline in VISA-A at Month 6(Baseline - Month 6)
  • Mean Change From Baseline in VISA-A at Month 12(Baseline - Month 12)
  • Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Week 6(Baseline - Week 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 3(Baseline - Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 6(Baseline - Month 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 12(Baseline - Month 12)
  • Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Week 6(Baseline - Week 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 3(Baseline - Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 6(Baseline - Month 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 12(Baseline - Month 12)
  • Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Week 6(Baseline - Week 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 3(Baseline - Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 6(Baseline - Month 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 12(Baseline - Month 12)
  • Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 3(Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Week 6(Baseline - Week 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 3(Baseline - Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 6(Baseline - Month 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 12(Baseline - Month 12)
  • Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Week 6(Week 6)
  • Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 3(Month 3)
  • Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 6(Month 6)
  • Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 12(Month 12)
  • Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 6(Month 6)
  • Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Week 6(Week 6)
  • Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 3(Month 3)
  • Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 6(Month 6)
  • Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 12(Month 12)
  • Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Week 6(Baseline - Week 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 3(Baseline - Month 3)
  • Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 6(Baseline - Month 6)
  • Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 12(Baseline - Month 12)
  • Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Week 6(Week 6)
  • Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 12(Month 12)
  • Number and Severity of Adverse Events (Safety and Tolerability)(From procedure (Day 0) through Month 12)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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