Chronic Tendinopathy
Conditions
Keywords
Micro-fragmented adipose tissue, MFAT, autologous fat grafting, adipose-derived stem cells, regenerative medicine, orthobiologics, percutaneous tenotomy,, ultrasound-guided injection, chronic tendinopathy, tendinopathy, lateral epicondylitis, rotator cuff tendinopathy, Achilles tendinopathy
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.
Interventions
PROCEDUREMicro-Fragmented Adipose Tissue (MFAT) injection
Autologous microfragmented adipose tissue (MFAT), i.e., mechanically concentrated autologous lipoaspirate, prepared and delivered in a single, same-day, point-of-care procedure. Under local anesthesia, 5-15 cc of subcutaneous abdominal fat is harvested by small-volume manual liposuction. The lipoaspirate is sterilely rinsed and concentrated by manual rolling on a non-adherent (Telfa) dressing; no enzymatic (collagenase) digestion, cell isolation, culture, or expansion is performed (minimal manipulation). Under ultrasound guidance, percutaneous tenotomy (needle fenestration) of the target tendon is performed, followed by a single intratendinous injection of 1-3 cc of the concentrated graft into the area of tendinopathy. One-time administration; route is percutaneous intratendinous injection. No exogenous cells, additives, scaffolds, or culture are used; the graft is autologous and delivered within the same surgical procedure.
Sponsors
Weill Medical College of Cornell University
The Plastic Surgery Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Reported Pain (NRS) at Week 6 | Baseline, Week 6 | Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Week 6. (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome. |
| Change From Baseline in Patient-Reported Pain (NRS) at Month 3 | Baseline, Month 3 | Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 3 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome. |
| Change From Baseline in Patient-Reported Pain (NRS) at Month 12 | Baseline, Month 12 | Onset and durability of pain relief are assessed using the same 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable) at the non-primary time point. The outcome is the mean change from baseline at Month 12 (score minus baseline score). A negative change indicates improvement; a lower score is a better outcome. |
| Mean Change From Baseline in LEFS at Week 6 | Baseline - Week 6 | The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in LEFS at Month 3 | Baseline - Month 3 | The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in LEFS at Month 6 | Baseline - Month 6 | The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in LEFS at Month 12 | Baseline - Month 12 | The Lower Extremity Functional Scale (LEFS) is a 20-item patient-reported instrument scored 0-80, where higher scores indicate better lower-extremity function. It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Pain Subscale at Week 6 | Baseline - Week 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Pain Subscale at Month 3 | Baseline - Month 3 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Pain Subscale at Month 6 | Baseline - Month 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Pain Subscale at Month 12 | Baseline - Month 12 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Pain subscale, is scored 0-100, where higher scores indicate a better outcome (less pain). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Symptoms Subscale at Week 6 | Baseline - Week 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Symptoms Subscale at Month 3 | Baseline - Month 3 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Symptoms Subscale at Month 6 | Baseline - Month 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Symptoms Subscale at Month 12 | Baseline - Month 12 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Symptoms subscale, is scored 0-100, where higher scores indicate a better outcome (fewer symptoms, including stiffness). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Week 6 | Baseline - Week 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 3 | Baseline - Month 3 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 6 | Baseline - Month 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at Month 12 | Baseline - Month 12 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Daily Living (ADL) subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with daily activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Sport/Recreation Subscale at Week 6 | Baseline - Week 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 3 | Baseline - Month 3 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 6 | Baseline - Month 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Sport/Recreation Subscale at Month 12 | Baseline - Month 12 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Function in Sport and Recreation subscale, is scored 0-100, where higher scores indicate a better outcome (less difficulty with sport and recreational activities). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Quality of Life Subscale at Week 6 | Baseline - Week 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Quality of Life Subscale at Month 3 | Baseline - Month 3 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Quality of Life Subscale at Month 6 | Baseline - Month 6 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in HOOS Quality of Life Subscale at Month 12 | Baseline - Month 12 | The Hip Disability and Osteoarthritis Outcome Score (HOOS), Hip-Related Quality of Life subscale, is scored 0-100, where higher scores indicate a better outcome (better hip-related quality of life). It is administered only to participants whose treated tendinopathy is at the hip; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in DASH at Week 6 | Baseline - Week 6 | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a negative change indicates improvement. |
| Mean Change From Baseline in DASH at Month 3 | Baseline - Month 3 | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a negative change indicates improvement. |
| Mean Change From Baseline in DASH at Month 6 | Baseline - Month 6 | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a negative change indicates improvement. |
| Mean Change From Baseline in DASH at Month 12 | Baseline - Month 12 | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is scored 0-100, where higher scores indicate greater disability (worse function). It is administered only to participants whose treated tendinopathy is in the hand/wrist; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a negative change indicates improvement. |
| Mean Change From Baseline in MEPI at Week 6 | Baseline - Week 6 | The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in MEPI at Month 3 | Baseline - Month 3 | The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in MEPI at Month 6 | Baseline - Month 6 | The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in MEPI at Month 12 | Baseline - Month 12 | The Mayo Elbow Performance Index (MEPI) is scored 0-100, where higher scores indicate better elbow function. It is administered only to participants whose treated tendinopathy is at the elbow; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Mean Change From Baseline in VISA-A at Week 6 | Baseline - Week 6 | The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Week 6; a positive change indicates improvement. |
| Mean Change From Baseline in VISA-A at Month 3 | Baseline - Month 3 | The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 3; a positive change indicates improvement. |
| Mean Change From Baseline in VISA-A at Month 6 | Baseline - Month 6 | The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 6; a positive change indicates improvement. |
| Mean Change From Baseline in VISA-A at Month 12 | Baseline - Month 12 | The Victorian Institute of Sport Assessment-Achilles (VISA-A) is scored 0-100, where higher scores indicate better (less symptomatic) tendon function. It is administered only to participants whose treated tendinopathy is at the Achilles tendon; it is not administered to participants treated at other anatomical sites, who are assessed with the instrument specific to their site. The outcome is the mean change from baseline to Month 12; a positive change indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Week 6 | Baseline - Week 6 | Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Week 6; a negative change (reduction in thickness toward normal) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 3 | Baseline - Month 3 | Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 3; a negative change (reduction in thickness toward normal) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 6 | Baseline - Month 6 | Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 6; a negative change (reduction in thickness toward normal) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at Month 12 | Baseline - Month 12 | Maximal anteroposterior thickness of the treated tendon, measured on grayscale B-mode ultrasound at the site of maximal pathology and reported in millimeters. Tendinopathy is characterized by tendon thickening, so the outcome is the mean change from baseline to Month 12; a negative change (reduction in thickness toward normal) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Week 6 | Baseline - Week 6 | Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Week 6; a negative change (a lower score, indicating more normal architecture) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 3 | Baseline - Month 3 | Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 3; a negative change (a lower score, indicating more normal architecture) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 6 | Baseline - Month 6 | Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 6; a negative change (a lower score, indicating more normal architecture) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at Month 12 | Baseline - Month 12 | Tendon fibrillar architecture graded by a blinded reviewer on a 4-point ordinal scale (0-3) adapted from the modified Öhberg structural score, where 0 = normal, uniformly fibrillar echotexture and 3 = severe loss of the fibrillar pattern with extensive structural disorganization. The outcome is the mean change from baseline to Month 12; a negative change (a lower score, indicating more normal architecture) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Week 6 | Baseline - Week 6 | Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 3 | Baseline - Month 3 | Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 6 | Baseline - Month 6 | Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at Month 12 | Baseline - Month 12 | Intratendinous hypoechogenicity graded by a blinded reviewer on a 4-point ordinal scale (0-3), where 0 = normal echogenicity and 3 = severe, extensive intratendinous hypoechoic change. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Week 6 | Baseline - Week 6 | Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Week 6; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 3 | Baseline - Month 3 | Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 3; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 6 | Baseline - Month 6 | Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 6; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at Month 12 | Baseline - Month 12 | Intratendinous and peritendinous neovascularity assessed on power-Doppler ultrasound and graded by a blinded reviewer on the modified Öhberg score, a 5-point ordinal scale (0-4) where 0 = no Doppler flow and 4 = extensive flow throughout the tendon. Neovascularization is frequently absent in chronic tendinopathy, so a floor at 0 is expected in many participants. The outcome is the mean change from baseline to Month 12; a negative change (a lower score) indicates improvement. |
| Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Week 6 | Week 6 | The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Week 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization. |
| Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 3 | Month 3 | The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 3, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization. |
| Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 6 | Month 6 | The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 6, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization. |
| Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at Month 12 | Month 12 | The number of participants in whom one or more intratendinous calcific foci are identified in the treated tendon on grayscale ultrasound at Month 12, reported as a count of participants. Calcification is not expected to resolve over the study period and is reported primarily for structural characterization. |
| Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Week 6 | Week 6 | The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Week 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence. |
| Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 3 | Month 3 | The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 3, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence. |
| Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 6 | Month 6 | The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 6, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence. |
| Tendon Architecture Assessment: Number of Participants With a Tendon Tear at Month 12 | Month 12 | The number of participants in whom a partial-thickness or full-thickness intrasubstance tear of the treated tendon is identified on ultrasound at Month 12, reported as a count of participants. Tear sidedness and thickness are recorded in the source documentation; this measure reports tear presence. |
| Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Week 6 | Baseline - Week 6 | Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Week 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan. |
| Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 3 | Baseline - Month 3 | Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 3; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan. |
| Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 6 | Baseline - Month 6 | Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 6; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan. |
| Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at Month 12 | Baseline - Month 12 | Among participants with a demonstrable tendon tear, the maximal dimension (length) of the tear measured on ultrasound, reported in millimeters. The outcome is the mean change from baseline to Month 12; a negative change (reduction in tear size) indicates improvement. Participants without a tear are handled per the statistical analysis plan. |
| Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Week 6 | Week 6 | Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment. |
| Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 3 | Month 3 | Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment. |
| Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 6 | Month 6 | Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment. |
| Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at Month 12 | Month 12 | Treatment satisfaction is measured with the Short Assessment of Patient Satisfaction (SAPS), a 7-item questionnaire. Each item is scored 0-4 for a total score of 0-28, where higher scores indicate greater satisfaction with treatment. |
| Number and Severity of Adverse Events (Safety and Tolerability) | From procedure (Day 0) through Month 12 | Safety is assessed as the number of participants with adverse events (AEs), with AEs tabulated by type, severity (e.g., mild/moderate/severe), seriousness, and attribution/relatedness to the procedure. Harvest (liposuction)-site and injection-site events are captured. |
Countries
United States
Contacts
CONTACTTerrence Green
PRINCIPAL_INVESTIGATORJaspal Singh, MD
Department of Rehabilitation Medicine | Weill Cornell Medicine
Outcome results
None listed