Patellar Tendinitis, Patellar Tendinopathy, Tendinopathy
Conditions
Keywords
stromal vascular fraction, patellar tendinopathy, injection
Brief summary
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
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.
Interventions
PROCEDUREStromal Vascular Fraction injection
intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional Pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol Visual Analogue Scale (EQ-VAS) | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | EQ-VAS, which asks patients to indicate their overall health on a vertical visual analogue scale, ranging from worst possible to best possible health. |
| EQ-5D(EuroQol) | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | the EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems (no, some, extreme) on five dimensions. |
| Visual Analog Scale - VAS | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | Analogue scale represented by a line of 10 cm length, ranging from absence of pain to the worst imaginable pain |
| Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 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 |
| MRI evaluation | baseline and 6 month | MRI performing and evaluation |
| ultrasound | baseline, 6 and 12 months | ultrasound performing and thickness evaluation of the tendon |
| Tegner score | Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone) | 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. |
Countries
Italy
Outcome results
None listed