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Active, not recruiting Not applicable

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

NCT04567732 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-02-22
Last updated
2025-08-03

Condition(s) studied

Bilateral Knee OsteoarthritisAutologous Adipose Tissue

Investigational drug(s) / intervention(s)

injection of Filtered Autologous Adipose TissuePlacebo

injection of Filtered Autologous Adipose Tissue: Single injection of Filtered Autologous Adipose Tissue

Placebo: Single injection of Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — 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).

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04567732 on ClinicalTrials.gov ↗ ← All trials in Italy