Active, not recruitingNo phase
Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 100 people enrolled
- Started
- 22 Feb 2021
- Ended
- Apr 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- injection of Filtered Autologous Adipose Tissue
- Placebo
- Record updated
- 3 August 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
- An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19
- Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment)
- Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up
Who cannot take part
- Patients who abuse alcoholic beverages, drugs or medicines
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening
- Patients who have had knee surgery in the 12 months prior to screening
- Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy
- 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
- Patients with uncontrolled diabetes mellitus
- Patients with uncontrolled thyroid metabolic disorders
- Patients incapable of understanding and wanting
- Patients with misalignment of the lower limbs above 10 degrees
- Body Mass Index > 40
- Pregnant or lactating state or intention to become pregnant during the period of participation in the study
- Patients with insufficient abdominal adipose tissue, assessed by the investigator
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.
The 2 groups in the trial
- Filtered Autologous Adipose TissueTreatment being tested
based on randomization one of the two knees will be treated with a single injection of Filtered Autologous Adipose Tissue
Treatment: injection of Filtered Autologous Adipose Tissue
- PlaceboPlacebo, for comparison
based on randomization one of the two knees will be treated with a single injection of Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo
- Record updated
- 3 August 2025