Injections of SVF in Ankle Osteoarthritis

Study Overview
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Brief Summary
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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. 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.

Detailed Description
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30 patients with moderate to severe ankle osteoarthritis (grade 1-3 according to Giannini's classification) will be included in this pilot study, in which patients will be treated with single injection of Stromal Vascular Fraction - SVF ,obtained by processing the patient's abdominal adipose tissue. All patients will be examined with a baseline clinical visit. For obtaining SVF, will be carried out a routinely performed procedure aimed at obtaining a small amount of adipose tissue from all patients. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12 and 24 months.

Official Title
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SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study

Conditions
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Ankle Osteoarthritis

Intervention / Treatment
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* Procedure: SVF injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with BMI>30 kg/m2 Patients with Rheumatoid Arthritis 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 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; Patients with concomitant neurological pathologies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 30 patients with moderate to severe ankle osteoarthritis (Giannini grade 1-3) will be included in the study and the affected ankle will be treated with a single injection of SVF (Stromal vascular fraction). Each patient will sign an informed consent for the participation in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF injection<br>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. | Procedure: SVF injection<br>* Patients with ankle osteoarthritis will be treated with a single injection of 5 cc of SVF (stromal vascular fraction), obtained from patient's abdominal adipose tissue and concentrated through OPTYFAT device. Infiltration of the ankle, occurs from the safest portal, that is, from the antero- medial, between the tibialis anterior and the saphenous vein and nerve at the level of the articular rima.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOS (Ankle Osteoarthritis Scale) | AOS is a score divided into 2 subscales, each with 9 questions. The first section assesses pain, while the other assesses ankle function. The answers consist of a rating on a 100-mm-long horizontal visual analog scale (from no pain to worst pain imaginable for pain section, and no limitation and extremely limited for function section). The highest possible value of the score is 100 (worst score) and the lowest (best score) is 0. | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS (The American Orthopedic Foot and Ankle Score): | AOFAS is the most validated and widely used clinical and functional assessment tool for the ankle and foot. The score consists of 9 questions grouped into 3 categories for a total of 100 points maximum: Pain (up to 40 points), Function (up to 50 points) and Alignment (up to 10 points).100 points represent the best possible clinical-functional condition and absence of symptoms, 0 points represent the worst possible clinical-functional condition. AOFAS is a tool that combines the subjective component of the patients with the objective evaluation by the physician. | baseline, 1,3,6,12,24 months | 
| VAS-pain (Visual Analogue Scale) | VAS Iis represented by a line 10 cm long: one end indicates the absence of pain and corresponds to 0, the other end indicates the worst pain imaginable and corresponds to 10. The scale is filled by the patient who is asked to draw a mark on the line representing the perceived pain. The distance measured from the 0 end corresponds to the subjective measure of pain | baseline, 1,3,6,12,24 months | 
| Range Of Motion (ROM) | Baseline and follow-up measurement of ROM range of motion of the treated ankle | baseline, 1,3,6,12,24 months | 
| SF-12 (12-Item Short Form Survey): | SF-12 consist of 12 questions that permit to investigate the two synthetic indices, PCS Physical Component Summary for the Physical State and MCS Mental Component Summary for the Mental State. The main strengths of this questionnaire are its brevity and relative ease of use. | baseline, 1,3,6,12,24 months | 
| EQ-5D (EuroQoL) Current Health Assessment | The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems (no, some, extreme) on five dimensions. | baseline, 1,3,6,12,24 months | 
| EQ-VAS | EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). | baseline, 1,3,6,12,24 months | 
| Patient Acceptable Symptom State (PASS): | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering yes or no. | baseline, 1,3,6,12,24 months | 
| Final treatment opinion | The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; Full recovery, much better, somewhat better, no change, a little worse, much worse. | baseline, 1,3,6,12,24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SVF, ankle, ankle osteoarthritis, stromal vascular fraction, injection treatment, ADSCs, Pilot study, Adipose Derived Stromal Cell's