Autologous microfragmented fat injections with or without hyaluronic acid for both painful knees

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, within-patient trial enrolling 100 people with symptomatic bilateral knee osteoarthritis. Each participant will receive microfragmented autologous adipose tissue (MFAT) with high-molecular-weight hyaluronic acid in one knee and MFAT with saline placebo in the other knee, with allocation randomized and concealed. Procedures include abdominal liposuction to harvest fat, microfragmentation, and intra-articular injections, and clinical follow-up visits at baseline, 2, 6, 12, and 24 months. Outcomes include knee pain, function measures, and safety monitoring of adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged between 18 and 75;
2. Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale;
3. Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees;
4. Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment);
5. Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of

4\. Failure, defined as persistent symptoms, after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment); 5. Ability and consent of patients to actively participate in the rehabilitation and follow-up protocol; 6. Signature of informed consent

Exclusion Criteria:

1. Patients incapable of understanding and willing;
2. Diagnosis of active neoplasia;
3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, active viral hepatitis; chondrocalcinosis;
4. Patients with uncontrolled diabetes mellitus;
5. Patients with uncontrolled thyroid metabolic disorders;
6. Patients who abuse alcohol, drugs, or medications;
7. Patients with lower limb misalignment greater than 5°;
8. Body Mass Index \> 35 kg/m2;
9. Pregnancy or breastfeeding, or plans to become pregnant during the study period .
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 undergone knee surgery in the 12 months prior to screening.
12. Patients with insufficient abdominal adipose tissue, as assessed by the investigator.

Where it's running

• IRCCS Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
• Study coordinator: Alessandro Di Martino, MD
• Email: alessandro.dimartino@ior.it
• Phone: 0516366567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.