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

Primary Purpose

Patellar Tendinitis, Tendinopathy, Patellar Tendinopathy

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Stromal Vascular Fraction injection

About this trial

This is an interventional treatment trial for Patellar Tendinitis focused on measuring stromal vascular fraction, patellar tendinopathy, injection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stromal Vascular Fraction injection

Arm Description

intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire

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.

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.

Visual Analog Scale - VAS

Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "

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.

MRI evaluation

MRI performing and evaluation

ultrasound

ultrasound performing and thickness evaluation of the tendon

Full Information

NCT ID

NCT04753853

First Posted

February 12, 2021

Last Updated

April 18, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04753853

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

February 10, 2022 (Actual)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patellar Tendinitis, Tendinopathy, Patellar Tendinopathy

Keywords

stromal vascular fraction, patellar tendinopathy, injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Interventional Pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stromal Vascular Fraction injection

Arm Type

Experimental

Arm Description

intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction

Intervention Type

Procedure

Intervention Name(s)

Stromal Vascular Fraction injection

Intervention Description

intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction

Primary Outcome Measure Information:

Title

Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire

Description

Time Frame