NCT04753853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

February 12, 2021

Last Update Submit

September 11, 2025

Conditions

Patellar TendinitisTendinopathyPatellar Tendinopathy

Keywords

stromal vascular fractionpatellar tendinopathyinjection

Outcome Measures

Primary Outcomes (1)

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

    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

    6 months

Secondary Outcomes (7)

  • 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)

  • EuroQol Visual Analogue Scale (EQ-VAS)

    Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)

  • EQ-5D(EuroQol)

    Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)

  • Visual Analog Scale - VAS

    Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)

  • Tegner score

    Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)

  • +2 more secondary outcomes

Study Arms (1)

Stromal Vascular Fraction injection

EXPERIMENTAL

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

Procedure: Stromal Vascular Fraction injection

Interventions

Stromal Vascular Fraction injectionPROCEDURE

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

Stromal Vascular Fraction injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ultrasound or MRI signs of patellar tendon pathology

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40124, Italy

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Interventional Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 15, 2021

Study Start

July 1, 2021

Primary Completion

February 10, 2022

Study Completion

May 5, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

IT(1)