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

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ClinicalTrials.gov Identifier: NCT04753853
Recruitment Status : Not yet recruiting
First Posted : February 15, 2021
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Stefano Zaffagnini, 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.

Condition or disease Intervention/treatment Phase
Patellar Tendinitis Tendinopathy Patellar Tendinopathy Procedure: Stromal Vascular Fraction injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : September 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753853


Contacts
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Contact: Daniele Andreani, M.Sc. 0516366072 daniele.andreani@ior.it
Contact: Stefano Zaffagnini, MD, Prof

Sponsors and Collaborators
Istituto Ortopedico Rizzoli
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Responsible Party: Stefano Zaffagnini, Prof., Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04753853    
Other Study ID Numbers: Lipo-Tend
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefano Zaffagnini, Istituto Ortopedico Rizzoli:
stromal vascular fraction
patellar tendinopathy
injection
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries