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

NCT ID: NCT04753853

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-05-05

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.

Conditions

Patellar Tendinitis; Tendinopathy; Patellar Tendinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stromal Vascular Fraction injection

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

Group Type: EXPERIMENTAL

Stromal Vascular Fraction injection

Intervention Type: PROCEDURE

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

Interventions

Stromal Vascular Fraction injection

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

Lipo-Tend

Identifier Type: -

Identifier Source: org_study_id