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

Not Applicable

Active, not recruiting

• Conditions: Tendinopathy; Patellar Tendinitis; Patellar Tendinopathy
• Interventions: Procedure: Stromal Vascular Fraction injection

• Registration Number: NCT04753853
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-07-01
• Primary Completion: 2022-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire	6 months	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

Name	Time	Method
Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire	Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)	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
EuroQol Visual Analogue Scale (EQ-VAS)	Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)	EQ-VAS, which asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" to "best possible" health.
Tegner score	Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)	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	baseline and 6 month	MRI performing and evaluation
ultrasound	baseline, 6 and 12 months	ultrasound performing and thickness evaluation of the tendon
EQ-5D(EuroQol)	Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)	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	Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)	Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy