Injections of SVF in Ankle Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2024-10-28

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.

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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.

Conditions

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Ankle Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SVF injection

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.

Group Type EXPERIMENTAL

SVF injection

Intervention Type PROCEDURE

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.

Interventions

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SVF injection

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients suffering from moderate to severe unilateral ankle arthrosis (grade 1-3 according to Giannini's classification);
2. Patients who gave written informed consent to participate in the study;
3. .Patients with MRI examination showing absence of osteochondral lesion;
4. Patients who have given their willingness to come to the Institute for follow-up visits

Exclusion Criteria

1. Patients with BMI\>30 kg/m2
2. Patients with Rheumatoid Arthritis
3. Patients with chronic inflammatory joint disease;
4. Patients with acute or chronic infections;
5. Patients with pre-existing abnormalities of gait kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasia);
6. Patients with severe knee arthrosis (Kellgren-Lawrence\>3);
7. Patients with ankle deformities greater than 8°;
8. Patients with pain on other joints of the foot;
9. Patients with severe postural instability;
10. Patients with cognitive deficits;
11. Patients with concomitant neurological pathologies

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No