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NCT Number: NCT04753853

Stromal Vascular Fraction (SVF) Injection in the Treatment of 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.

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Key information

Conditions

Patellar Tendinitis Muscular Diseases Musculoskeletal Diseases Patellar Tendinopathy Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Stromal Vascular Fraction injection

Procedure

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

Primary outcomes

  1. Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire

    Time frame: 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 outcomes

  1. Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire

    Time frame: 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

  2. EuroQol Visual Analogue Scale (EQ-VAS)

    Time frame: 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.

  3. EQ-5D(EuroQol)

    Time frame: 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.

  4. Visual Analog Scale - VAS

    Time frame: 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 "

  5. Tegner score

    Time frame: 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.

  6. MRI evaluation

    Time frame: baseline and 6 month

    MRI performing and evaluation

  7. ultrasound

    Time frame: baseline, 6 and 12 months

    ultrasound performing and thickness evaluation of the tendon

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Feb 15, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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