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

Tendinopathy Clinical Trial

Official title:

Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04753853
• Other study ID #: Lipo-Tend
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Patellar Tendinitis
• Patellar Tendinopathy
• Tendinopathy

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