Stromal Vascular Fraction (SVF) Injection in the Treatment of Patellar Tendinopathy

Study Overview
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Brief Summary
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The aim of the study is the evaluation of clinical and radiological results after the treatment of patellar tendinopathy through the injection of autologous ultrasound-guided, intra- and peri-tendon stromal vascular fraction.

Detailed Description
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After being informed about the study and potential risks, all patients giving written informed consent will be treated according to the study protocol. Every patients will undergo to a single peri- and intra- tendon injection with Autologous Stromal Vascula Fraction (SVF). At baseline and at every follow-ups patients will be evaluated clinically and radiologically. In particular, clinical evaluation and questionnaires will be performed at baseline, 1, 3, 6, 12 and 24 months visits, Ultrasound will be performed at baseline, 6 and 12 months visits. MRI will be performed at baseline and 6 months visits.

Official Title
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Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy

Conditions
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Patellar Tendinitis, Tendinopathy, Patellar Tendinopathy

Intervention / Treatment
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* Procedure: Stromal Vascular Fraction injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasound or MRI signs of patellar tendon pathology Exclusion Criteria: BMI > 30 Patients suffering from: rheumatic diseases, diabetes, infectious processes, epilepsy, severe osteoporosis Patients undergoing intra-tendon infiltration of another substance within the previous 6 months; Patients who had patellar tendon surgery within the previous 12 months; Immunodepression On going systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stromal Vascular Fraction injection<br>intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction | Procedure: Stromal Vascular Fraction injection<br>* intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire | VISA-P score is a questionnaire that assesses symptoms, simple tests of function, and the ability to play sports. It contains 8 questions about patellar tendinosis, max score for asymptomatic individual is 100; theoretical minimum is 0 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire | VISA-P score is a questionnaire that assesses symptoms, simple tests of function, and the ability to play sports. It contains 8 questions about patellar tendinosis, max score for asymptomatic individual is 100; theoretical minimum is 0 | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 
| EuroQol Visual Analogue Scale (EQ-VAS) | EQ-VAS, which asks patients to indicate their overall health on a vertical visual analogue scale, ranging from worst possible to best possible health. | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 
| EQ-5D(EuroQol) | the EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems (no, some, extreme) on five dimensions. | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 
| Visual Analog Scale - VAS | Analogue scale represented by a line of 10 cm length, ranging from absence of pain to the worst imaginable pain  | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 
| Tegner score | Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level. | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 
| MRI evaluation | MRI performing and evaluation | baseline and 6 month | 
| ultrasound | ultrasound performing and thickness evaluation of the tendon | baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stromal vascular fraction, patellar tendinopathy, injection