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
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 29 Sept 2025
- Expected to end
- Sept 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MFAT + HA left knee - MFAT + placebo right knee
- MFAT + HA right knee - MFAT + placebo left knee
- Record updated
- 3 December 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Male or female patients aged between 18 and 75
- Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale
- Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees
- Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment)
- Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of
- 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
Who cannot take part
- Patients who abuse alcohol, drugs, or medications
- Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening
- Patients who have undergone knee surgery in the 12 months prior to screening
- 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
- Patients with uncontrolled diabetes mellitus
- Patients with uncontrolled thyroid metabolic disorders
- Patients incapable of understanding and willing
- Diagnosis of active neoplasia
- Patients with lower limb misalignment greater than 5°
- Body Mass Index > 35 kg/m2
- Pregnancy or breastfeeding, or plans to become pregnant during the study period
- Patients with insufficient abdominal adipose tissue, as assessed by the investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Italy
- IRCCS Istituto ortopedico RizzoliBologna, ItalyContact: Alessandro Di Martino, MDTaking people
About the trial
What the trial wants to find out
The HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation.
Read full original descriptionShow less
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.
The 2 groups in the trial
- MFAT + HA left knee - MFAT + placebo right kneeTreatment being tested
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 kneeExisting treatment, for comparison
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%)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Fit questions
- Built from NCT07121556, who can take part
- Record updated
- 3 December 2025