Clinical trial NCT04998162: Injections of SVF in Ankle Osteoarthritis
Official title: SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Osteoarthritis
Keywords: SVF
ankle
ankle osteoarthritis
stromal vascular fraction
injection treatment
ADSCs
Pilot study
Adipose Derived Stromal Cell's
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: AOS (Ankle Osteoarthritis Scale)
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: AOFAS (The American Orthopedic Foot and Ankle Score):
timeFrame: baseline, 1,3,6,12,24 months
measure: VAS-pain (Visual Analogue Scale)
timeFrame: baseline, 1,3,6,12,24 months
measure: Range Of Motion (ROM)
timeFrame: baseline, 1,3,6,12,24 months
measure: SF-12 (12-Item Short Form Survey):
timeFrame: baseline, 1,3,6,12,24 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: baseline, 1,3,6,12,24 months
measure: EQ-VAS
timeFrame: baseline, 1,3,6,12,24 months
measure: Patient Acceptable Symptom State (PASS):
timeFrame: baseline, 1,3,6,12,24 months
measure: Final treatment opinion
timeFrame: baseline, 1,3,6,12,24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Massimiliano Mosca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barfod KW, Blond L. Treatment of osteoarthritis with autologous and microfragmented adipose tissue. Dan Med J. 2019 Oct;66(10):A5565.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.