Injections of SVF in Ankle Osteoarthritis

NCT04998162 | Completed

• 1 other identifier: ADSCs-INT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Osteoarthritis

Keywords

SVF; ankle; ankle osteoarthritis; stromal vascular fraction; injection treatment; ADSCs; Pilot study; Adipose Derived Stromal Cell's

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• AOFAS (The American Orthopedic Foot and Ankle Score):

  baseline, 1,3,6,12,24 months

• VAS-pain (Visual Analogue Scale)

  baseline, 1,3,6,12,24 months

• Range Of Motion (ROM)

  baseline, 1,3,6,12,24 months

• SF-12 (12-Item Short Form Survey):

  baseline, 1,3,6,12,24 months

• EQ-5D (EuroQoL) Current Health Assessment

  baseline, 1,3,6,12,24 months

Study Arms (1)

SVF injection

EXPERIMENTAL

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

Interventions

SVF injection 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.

SVF injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (6)

• Barfod KW, Blond L. Treatment of osteoarthritis with autologous and microfragmented adipose tissue. Dan Med J. 2019 Oct;66(10):A5565.

  PMID: 31571571 BACKGROUND

• Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.

  PMID: 30355323 BACKGROUND

• Shimozono Y, Dankert JF, Kennedy JG. Arthroscopic Debridement and Autologous Micronized Adipose Tissue Injection in the Treatment of Advanced-Stage Posttraumatic Osteoarthritis of the Ankle. Cartilage. 2021 Dec;13(1_suppl):1337S-1343S. doi: 10.1177/1947603520946364. Epub 2020 Aug 6.

  PMID: 32757620 BACKGROUND

• Freitag J, Wickham J, Shah K, Tenen A. Effect of autologous adipose-derived mesenchymal stem cell therapy in the treatment of an osteochondral lesion of the ankle. BMJ Case Rep. 2020 Jul 8;13(7):e234595. doi: 10.1136/bcr-2020-234595.

  PMID: 32641315 BACKGROUND

• McIntyre JA, Jones IA, Han B, Vangsness CT Jr. Intra-articular Mesenchymal Stem Cell Therapy for the Human Joint: A Systematic Review. Am J Sports Med. 2018 Dec;46(14):3550-3563. doi: 10.1177/0363546517735844. Epub 2017 Nov 3.

  PMID: 29099618 BACKGROUND

• Giannini S, Buda R, Faldini C, Vannini F, Romagnoli M, Grandi G, Bevoni R. The treatment of severe posttraumatic arthritis of the ankle joint. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:15-28. doi: 10.2106/JBJS.G.00544. No abstract available.

  PMID: 17908868 BACKGROUND

Study Officials

• Massimiliano Mosca, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: August 10, 2021
• Study Start: May 12, 2022
• Primary Completion: October 27, 2022
• Study Completion: October 28, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)