Patellar TendinitisNCT04753853
Stromal Vascular Fraction (SVF) Injection in the Treatment of Patellar Tendinopathy
A study testing Stromal Vascular Fraction injection in people with Patellar Tendinitis and Tendinopathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patellar Tendinitis, Tendinopathy, Patellar Tendinopathy
- What is being tested?
- Stromal Vascular Fraction injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ultrasound or MRI signs of patellar tendon pathology
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infiltrative Treatment of Stromal Vascular Fraction in 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.
Read the 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
- Being tested
- Stromal Vascular Fraction injection
- Keywords
- stromal vascular fraction, patellar tendinopathy, injection
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal Vascular Fraction injectionProcedure or surgery
intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction
| Study group | Role | What they receive |
|---|---|---|
| Stromal Vascular Fraction injection | Experimental | intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction Receives: Procedure: Stromal Vascular Fraction injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
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
Measured: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
EuroQol Visual Analogue Scale (EQ-VAS)
EQ-VAS, which asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" to "best possible" health.
Measured: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
EQ-5D(EuroQol)
the EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
Measured: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
Visual Analog Scale - VAS
Analogue scale represented by a line of 10 cm length, ranging from "absence of pain" to "the worst imaginable pain "
Measured: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
Tegner score
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.
Measured: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
MRI evaluation
MRI performing and evaluation
Measured: baseline and 6 month
ultrasound
ultrasound performing and thickness evaluation of the tendon
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Jul 2021
- Primary completion10 Feb 2022
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinitisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional Pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753853
- Sponsor's protocol ID
- Lipo-Tend
- Status last verified
- Sep 2025
- First submitted
- 12 Feb 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infiltrative Treatment of Stromal Vascular Fraction in Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT04753853
- Acronym / sponsor ID
- Lipo-Tend
- Conditions
- Patellar Tendinitis, Tendinopathy, Patellar Tendinopathy
- Keywords
- stromal vascular fraction, patellar tendinopathy, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional Pilot study
| Arm | Type | Receives |
|---|---|---|
| Stromal Vascular Fraction injection | Experimental | Procedure: Stromal Vascular Fraction injectionintra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Ultrasound or MRI signs of patellar tendon pathology
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stromal Vascular Fraction injectionintra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction | Procedure or surgery | Stromal Vascular Fraction injection |
Primary outcome
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
7 secondary outcomes
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)
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-5D(EuroQol)
Time frame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
Visual Analog Scale - VAS
Time frame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
Tegner score
Time frame: Baseline, 1, 3, 6, and 12 months (at 24 month the questionnaire will be performed by telephone)
MRI evaluation
Time frame: baseline and 6 month
ultrasound
Time frame: baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stromal Vascular Fraction injection in people with Patellar Tendinitis and Tendinopathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.