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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

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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.

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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