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Compares treatment options for Osteoarthritis Knees Both
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
ClinicalTrials.gov ID: NCT07121556
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of 4\. Failure...
You likely can't join if
- Patients incapable of understanding and willing;
- Diagnosis of active neoplasia;
- Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another...
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients who abuse alcohol, drugs, or medications;
See the full eligibility criteria
- 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 4\. Failure, defined as persistent symptoms, after at least 6 months of conservative...
- Patients incapable of understanding and willing;
- Diagnosis of active neoplasia;
- 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...
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients who abuse alcohol, drugs, or medications;
- 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 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.
- Patients with insufficient abdominal adipose tissue, as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.