Clinical trial NCT04753853: Stromal Vascular Fraction (SVF) Injection in the Treatment of Patellar Tendinopathy
Official title: Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patellar Tendinitis
Tendinopathy
Patellar Tendinopathy
Keywords: stromal vascular fraction
patellar tendinopathy
injection
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional Pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire
timeFrame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
measure: EuroQol Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
measure: EQ-5D(EuroQol)
timeFrame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
measure: Visual Analog Scale - VAS
timeFrame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
measure: Tegner score
timeFrame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
measure: MRI evaluation
timeFrame: baseline and 6 month
measure: ultrasound
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References: