Autologous Fat Grafting for the Treatment of Chronic Tendinopathy

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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 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 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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.