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

NCT07121556 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2025-09-29

Last updated

2025-12-03

Condition(s) studied

Osteoarthritis Knees Both

Investigational drug(s) / intervention(s)

MFAT + HA left knee - MFAT + placebo right kneeMFAT + HA right knee - MFAT + placebo left knee

MFAT + HA left knee - MFAT + placebo right knee: The left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)

MFAT + HA right knee - MFAT + placebo left knee: The right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)

Study summary

The HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation.

By means of a double-blind randomized controlled trial in patients with symptomatic bilateral OA of the knees, the clinical outcomes of autologous microfragmented adipose tissue injection associated with hyaluronic acid in one knee vs autologous microfragmented adipose tissue injection in the contralateral knee will be evaluated and compared. Each patient will then serve as his or her own control and not be informed of the knee assigned to the treatment group. In addition, it will be the aim of the study to evaluate the safety of the combined treatment by documenting any adverse events.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — 12 months
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome

Trial sites (1)

Facility	City	Region	Status
IRCCS Istituto Ortopedico Rizzoli	Bologna	Italy	Recruiting

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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 NCT07121556 on ClinicalTrials.gov ↗ ← All trials in Italy