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Completed

NCT Number: NCT04998162

Injections of SVF in Ankle Osteoarthritis

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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Key information

Conditions

Ankle Osteoarthritis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. AOS (Ankle Osteoarthritis Scale)

    Time frame: Baseline to 24 months

    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.

Secondary outcomes

  1. AOFAS (The American Orthopedic Foot and Ankle Score):

    Time frame: baseline, 1,3,6,12,24 months

    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.

  2. VAS-pain (Visual Analogue Scale)

    Time frame: baseline, 1,3,6,12,24 months

    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

  3. Range Of Motion (ROM)

    Time frame: baseline, 1,3,6,12,24 months

    Baseline and follow-up measurement of ROM range of motion of the treated ankle

  4. SF-12 (12-Item Short Form Survey):

    Time frame: baseline, 1,3,6,12,24 months

    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.

  5. EQ-5D (EuroQoL) Current Health Assessment

    Time frame: baseline, 1,3,6,12,24 months

    The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.

  6. EQ-VAS

    Time frame: baseline, 1,3,6,12,24 months

    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).

  7. Patient Acceptable Symptom State (PASS):

    Time frame: baseline, 1,3,6,12,24 months

    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.

  8. Final treatment opinion

    Time frame: baseline, 1,3,6,12,24 months

    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".

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2024
First posted
Aug 10, 2021
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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