NCT07748793尚未招募不适用
Autologous Fat Grafting for the Treatment of Chronic Tendinopathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Micro-Fragmented Adipose Tissue (MFAT) injection (Procedure)
结局指标
主要结局
Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months
时间窗: 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.
次要结局
- 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)
研究者
研究点 (1)
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