Actively Recruiting
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
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-03
100
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged between 18 and 75
- Radiographic evidence of bilateral knee osteoarthritis graded 2 to 4 on Kellgren-Lawrence scale
- Pain score of 4 or higher on Numeric Rating Scale in both knees
- Persistent symptoms after at least 6 months of conservative treatment (medications, physiotherapy, or injections)
- Ability and willingness to follow study procedures and instructions
- Signed informed consent
You will not qualify if you...
- Inability to understand or unwilling to participate
- Diagnosis of active cancer
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or other inflammatory arthritis
- HIV infection or active viral hepatitis
- Chondrocalcinosis
- Uncontrolled diabetes mellitus
- Uncontrolled thyroid metabolic disorders
- Abuse of alcohol, drugs, or medications
- Lower limb misalignment greater than 5 degrees
- Body Mass Index greater than 35 kg/m2
- Pregnancy, breastfeeding, or plans to become pregnant during the study
- Recent trauma or intra-articular injection within 6 months before screening
- Knee surgery within 12 months before screening
- Insufficient abdominal adipose tissue for harvesting
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40127
Actively Recruiting
Research Team
A
Alessandro Di Martino, MD
CONTACT
R
Roberta Licciardi, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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