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

I

Istituto Ortopedico Rizzoli

Status

Completed

Conditions

Patellar Tendinitis
Patellar Tendinopathy
Tendinopathy

Treatments

Procedure: Stromal Vascular Fraction injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04753853
Lipo-Tend

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Stromal Vascular Fraction injection
Experimental group
Description:
intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction
Treatment:
Procedure: Stromal Vascular Fraction injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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