Comparing filtered fat injections to placebo for knee osteoarthritis

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

This study tests if filtered fat injections can help people with knee osteoarthritis feel better compared to a placebo injection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bologna)
• Trial ID: NCT04567732 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of filtered autologous adipose tissue injections compared to placebo in patients with bilateral knee osteoarthritis. Participants will receive one injection of adipose tissue in one knee and a placebo in the other, with outcomes assessed through clinical and radiological measures over a follow-up period of 24 months. The study will involve randomization to ensure unbiased results and will include patients who have not found relief from previous conservative treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with bilateral knee osteoarthritis who have not responded to conservative treatments and have a specific pain score.

Not a fit: Patients with severe osteoarthritis or inflammatory joint diseases will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing knee osteoarthritis symptoms.

How similar studies have performed: Other studies have shown promise with similar approaches using autologous adipose tissue for joint conditions, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Daniele Andreani, M.Sc.

Conditions Bilateral Knee Osteoarthritis; Autologous Adipose Tissue; Arthrosis; Osteoarthrosis; Degenerative joint disease; Knee degenerative joint disease.; Bilateral; Fat tissue