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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Department of Rehabilitation Medicine WCMC
New York, New York, United States
Change From Baseline in Patient-Reported Pain Intensity (Numeric Rating Scale, NRS) at 6 Months
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.
Time frame: Baseline (pre-procedure) and Month 6
Change From Baseline in Patient-Reported Pain (NRS) at 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.
Time frame: Baseline, Week 6
Change From Baseline in Patient-Reported Pain (NRS) at 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.
Time frame: Baseline, Month 3
Change From Baseline in Patient-Reported Pain (NRS) at 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.
Time frame: Baseline, Month 12
Mean Change From Baseline in LEFS at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in LEFS at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in LEFS at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in LEFS at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in HOOS Pain Subscale at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in HOOS Pain Subscale at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in HOOS Pain Subscale at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in HOOS Pain Subscale at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in HOOS Symptoms Subscale at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in HOOS Symptoms Subscale at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in HOOS Symptoms Subscale at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in HOOS Symptoms Subscale at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in HOOS ADL (Function in Daily Living) Subscale at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in HOOS Sport/Recreation Subscale at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in HOOS Sport/Recreation Subscale at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in HOOS Sport/Recreation Subscale at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in HOOS Sport/Recreation Subscale at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in HOOS Quality of Life Subscale at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in HOOS Quality of Life Subscale at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in HOOS Quality of Life Subscale at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in HOOS Quality of Life Subscale at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in DASH at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in DASH at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in DASH at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in DASH at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in MEPI at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in MEPI at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in MEPI at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in MEPI at 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.
Time frame: Baseline - Month 12
Mean Change From Baseline in VISA-A at 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.
Time frame: Baseline - Week 6
Mean Change From Baseline in VISA-A at 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.
Time frame: Baseline - Month 3
Mean Change From Baseline in VISA-A at 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.
Time frame: Baseline - Month 6
Mean Change From Baseline in VISA-A at 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.
Time frame: Baseline - Month 12
Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at 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.
Time frame: Baseline - Week 6
Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at 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.
Time frame: Baseline - Month 3
Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at 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.
Time frame: Baseline - Month 6
Tendon Architecture Assessment: Mean Change From Baseline in Tendon Thickness at 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.
Time frame: Baseline - Month 12
Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at 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.
Time frame: Baseline - Week 6
Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at 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.
Time frame: Baseline - Month 3
Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at 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.
Time frame: Baseline - Month 6
Tendon Architecture Assessment: Mean Change From Baseline in Fibrillar Structure Grade at 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.
Time frame: Baseline - Month 12
Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at 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.
Time frame: Baseline - Week 6
Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at 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.
Time frame: Baseline - Month 3
Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at 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.
Time frame: Baseline - Month 6
Tendon Architecture Assessment: Mean Change From Baseline in Hypoechogenicity Grade at 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.
Time frame: Baseline - Month 12
Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at 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.
Time frame: Baseline - Week 6
Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at 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.
Time frame: Baseline - Month 3
Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at 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.
Time frame: Baseline - Month 6
Tendon Architecture Assessment: Mean Change From Baseline in Neovascularization Grade at 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.
Time frame: Baseline - Month 12
Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at 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.
Time frame: Week 6
Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at 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.
Time frame: Month 3
Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at 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.
Time frame: Month 6
Tendon Architecture Assessment: Number of Participants With Intratendinous Calcification at 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.
Time frame: Month 12
Tendon Architecture Assessment: Number of Participants With a Tendon Tear at 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.
Time frame: Week 6
Tendon Architecture Assessment: Number of Participants With a Tendon Tear at 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.
Time frame: Month 3
Tendon Architecture Assessment: Number of Participants With a Tendon Tear at 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.
Time frame: Month 6
Tendon Architecture Assessment: Number of Participants With a Tendon Tear at 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.
Time frame: Month 12
Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at 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.
Time frame: Baseline - Week 6
Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at 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.
Time frame: Baseline - Month 3
Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at 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.
Time frame: Baseline - Month 6
Tendon Architecture Assessment: Mean Change From Baseline in Maximal Tear Dimension at 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.
Time frame: Baseline - Month 12
Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at 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.
Time frame: Week 6
Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at 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.
Time frame: Month 3
Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at 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.
Time frame: Month 6
Participant Satisfaction (Short Assessment of Patient Satisfaction, SAPS) at 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.
Time frame: Month 12
Number and Severity of Adverse Events (Safety and Tolerability)
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.
Time frame: From procedure (Day 0) through Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.