NCT04998162

Injections of SVF in Ankle Osteoarthritis

SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Ankle Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-10-27
• Completion: 2024-10-28
• First posted: 2021-08-10
• Last updated: 2025-01-22

Locations

1 site across 1 country: Italy