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

Randomized Double- Blind Study on the Treatment of Symptomatic Bilateral Knee Osteoarthritis: Intra-articular Injection of Autologous Microfragmented Adipose Tissue and Hyaluronic Acid vs Intra Articular Injection of Autologous Microfragmented Adipose Tissue. Double-Blind Randomized Controlled Clinical Trial

This trial will test whether adding hyaluronic acid to injections of your own processed fat helps relieve pain and improve function in people with painful osteoarthritis in both knees.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT07121556 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with bilateral knee osteoarthritis (Kellgren-Lawrence grade 2–4), persistent pain of at least 4/10 in both knees, and failure of at least six months of conservative treatment are ideal candidates.

Not a fit: Patients with inflammatory arthritis, active cancer, inability to undergo liposuction or follow the protocol, or those with unilateral knee disease or pain below the entry threshold are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, combining hyaluronic acid with MFAT could provide greater pain relief and better knee function than MFAT alone, potentially delaying more invasive treatments.

How similar studies have performed: Small observational studies and case series report symptom improvements with MFAT or hyaluronic acid separately, but high-quality randomized evidence directly comparing the combination versus MFAT alone is limited.

Eligibility criteria

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 this trial is running

Bologna

• 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

Conditions: Osteoarthritis Knees Both, Osteoarthritis, Knees, HA, Micro-fragmented autologous adipose tissue, Hyaluronic acid, Intra-articular injection, Randomized double-blind study