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

Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tendinopathy; Patellar Tendinopathy; Patellar Tendinitis
• Intervention / Treatment: Procedure: Stromal Vascular Fraction injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Zaffagnini, MD, Prof

Study Locations

• Italy
  • Bologna, Italy, 40124
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stromal Vascular Fraction injection; intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction	Procedure: Stromal Vascular Fraction injection; intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
MRI evaluation	MRI performing and evaluation	baseline and 6 month
ultrasound	ultrasound performing and thickness evaluation of the tendon	baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: stromal vascular fraction; patellar tendinopathy; injection
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: Lipo-Tend

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No