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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04753853
Other study ID # Lipo-Tend
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date July 2025

Study information

Verified date April 2024
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 2025
Est. primary completion date February 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary MRI evaluation MRI performing and evaluation baseline and 6 month
Secondary ultrasound ultrasound performing and thickness evaluation of the tendon baseline, 6 and 12 months
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