Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

August 1, 2025 updated by: Istituto Ortopedico Rizzoli

Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.

After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients who meet the inclusion criteria and giving written informed consent will be randomized.

Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.

After the treatment patients will be followed up to 24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bologna, Italy, 40124
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
  2. An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.
  3. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);
  4. Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;

Exclusion Criteria:

  1. Patients incapable of understanding and wanting;
  2. Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
  3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;
  4. Patients with uncontrolled diabetes mellitus;
  5. Patients with uncontrolled thyroid metabolic disorders;
  6. Patients who abuse alcoholic beverages, drugs or medicines;
  7. Patients with misalignment of the lower limbs above 10 degrees;
  8. Body Mass Index > 40;
  9. Pregnant or lactating state or intention to become pregnant during the period of participation in the study.
  10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
  11. Patients who have had knee surgery in the 12 months prior to screening.
  12. Patients with insufficient abdominal adipose tissue, assessed by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Filtered Autologous Adipose Tissue
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
Combination product: injection of Filtered Autologous Adipose Tissue
Single injection of Filtered Autologous Adipose Tissue
Placebo Comparator: Placebo
based on randomization one of the two knees will be treated with a single injection of Placebo
Drug: Placebo
Single injection of Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 12 months
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Baseline, 1, 3, 6, and 24 months
It is a 0 - 100 standardized questionnaire widely used for the evaluation of patients with knee osteoarthrosis. The questionnaire is made by three subscale: Pain (5 questions ranging from 0 - 20), Stiffness (2 questions ranging from 0 - 8) and Function (17 questions ranging from 0 - 68).
Baseline, 1, 3, 6, and 24 months
Subjective International Knee Documentation Committee (IKDC - subjective score)
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
Questionnaire is specific for knee pathologies. it is composed by three subscales: Symptoms, Sport Activities and Knee Function. (Total score 0-100)
Baseline, 1, 3, 6, 12 and 24 months
Objective International Knee Documentation Committee (IKDC-Objective Score)
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
The presence of effusions and the degree of movement of the knee are evaluated, the worst value of one of these parameters determines the final value of the IKDC degree. There are four grades (A, B, C, D) which respectively identify a knee rated as normal, near normal, abnormal and severely abnormal;
Baseline, 1, 3, 6, 12 and 24 months
Tegner score
Time Frame: Before symptoms onset, at the baseline
describe and assess the sport activity with a score ranging from 0 to 10, where 0 means "inability" and 10 represent ability to perform "competitive sports".
Before symptoms onset, at the baseline
Patient Acceptable Symptom State (PASS)
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
tool for assessing patient satisfaction in consideration of their current degree of pain, function and daily activity. The patient will evaluate his degree of satisfaction by answering a dichotomous closed question (yes / no).
Baseline, 1, 3, 6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
0 - 100 scale where 100 is the "best possible health"and 0 is the "worst possible health"
Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Function
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
the scale is to expect the patient to select the number that best describes their functional disability status, from 0 to 10. The higher the value indicated the higher the degree of disability will be.
Baseline, 1, 3, 6, 12 and 24 months
Numeric Rating Scale (NRS) - Pain
Time Frame: Baseline, 1, 3, 6, 12 and 24 months
the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 means worst possible pain.
Baseline, 1, 3, 6, 12 and 24 months
Kellgren-Lawrence score
Time Frame: baseline and 24 months
grade 0 to 4 for the assessment of the knee osteoarthritis grade, where 4 is the worst possible grade.
baseline and 24 months
Magnetic Resonance Imaging
Time Frame: baseline and 12 months
evaluation of the knee joint
baseline and 12 months
overall judgement on the treatment
Time Frame: 6, 12 and 24 months
The patient must indicate the degree of satisfaction with the treatment carried out at the end of the clinical trial
6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AdipoBil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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