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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stromal Vascular Fraction injection | Experimental | intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stromal Vascular Fraction injection | Procedure | intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40124 | Italy |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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Interventional Pilot study
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| 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 |