Injections of SVF in Ankle Osteoarthritis
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 12 May 2022
- Ended
- 28 Oct 2024
- Type of study
- Interventional
- Treatments tested
- SVF injection
- Record updated
- 22 January 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patients suffering from moderate to severe unilateral ankle arthrosis (grade 1-3 according to Giannini's classification)
- Patients who gave written informed consent to participate in the study
- .Patients with MRI examination showing absence of osteochondral lesion
- Patients who have given their willingness to come to the Institute for follow-up visits
Who cannot take part
- Patients with concomitant neurological pathologies
- Patients with chronic inflammatory joint disease
- Patients with acute or chronic infections
- Patients with pre-existing abnormalities of gait kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasia)
- Patients with BMI>30 kg/m2
- Patients with Rheumatoid Arthritis
- Patients with severe knee arthrosis (Kellgren-Lawrence>3)
- Patients with ankle deformities greater than 8°
- Patients with pain on other joints of the foot
- Patients with severe postural instability
- Patients with cognitive deficits
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The aim of this pilot study is to analyze the effect of SVF injection produced by adipose tissue processing, in terms of clinical improvement, in patients with moderate to severe (stage 1-3) ankle osteoarthritis. Evaluation will be performed by administering pre-operative and post-operative clinical assessment questionnaires.
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Patients will be followed-up with a pre-operative evaluation and post-operative evaluations at 30 days, 3-6-12, and 24 months after application.
The group in the trial
- SVF injectionTreatment being tested
All patients with ankle osteoarthritis will be treated with a single injection of SVF, obtained from the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit and will be followed-up with clinical evaluation at 1, 3, 6, 12 and 24 months.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study
- Record updated
- 22 January 2025