Back to resultsInjections of SVF in Ankle Osteoarthritis
Primary Purpose
Ankle Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SVF injection
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Osteoarthritis focused on measuring SVF, ankle, ankle osteoarthritis, stromal vascular fraction, injection treatment, ADSCs, Pilot study, Adipose Derived Stromal Cell's
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SVF injection
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
AOFAS (The American Orthopedic Foot and Ankle Score):
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.
VAS-pain (Visual Analogue Scale)
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
Range Of Motion (ROM)
Baseline and follow-up measurement of ROM range of motion of the treated ankle
SF-12 (12-Item Short Form Survey):
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.
EQ-5D (EuroQoL) Current Health Assessment
The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
EQ-VAS
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).
Patient Acceptable Symptom State (PASS):
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.
Final treatment opinion
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".
Full Information
NCT ID
NCT04998162
First Posted
May 18, 2021
Last Updated
October 9, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04998162
Brief Title
Injections of SVF in Ankle Osteoarthritis
Official Title
SVF in Infiltrative Therapy for Ankle Osteoarthritis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Osteoarthritis
Keywords
SVF, ankle, ankle osteoarthritis, stromal vascular fraction, injection treatment, ADSCs, Pilot study, Adipose Derived Stromal Cell's
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SVF injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SVF injection
Intervention Description
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 Outcome Measure Information:
Title
AOS (Ankle Osteoarthritis Scale)
Description
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.
Time Frame
Baseline to 24 months
Secondary Outcome Measure Information:
Title
AOFAS (The American Orthopedic Foot and Ankle Score):
Description
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.
Time Frame
baseline, 1,3,6,12,24 months
Title
VAS-pain (Visual Analogue Scale)
Description
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
Time Frame
baseline, 1,3,6,12,24 months
Title
Range Of Motion (ROM)
Description
Baseline and follow-up measurement of ROM range of motion of the treated ankle
Time Frame
baseline, 1,3,6,12,24 months
Title
SF-12 (12-Item Short Form Survey):
Description
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.
Time Frame
baseline, 1,3,6,12,24 months
Title
EQ-5D (EuroQoL) Current Health Assessment
Description
The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
Time Frame
baseline, 1,3,6,12,24 months
Title
EQ-VAS
Description
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).
Time Frame
baseline, 1,3,6,12,24 months
Title
Patient Acceptable Symptom State (PASS):
Description
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.
Time Frame
baseline, 1,3,6,12,24 months
Title
Final treatment opinion
Description
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".
Time Frame
baseline, 1,3,6,12,24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimiliano Mosca, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31571571
Citation
Barfod KW, Blond L. Treatment of osteoarthritis with autologous and microfragmented adipose tissue. Dan Med J. 2019 Oct;66(10):A5565.
Results Reference
background
PubMed Identifier
30355323
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.
Results Reference
background
PubMed Identifier
32757620
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.
Results Reference
background
PubMed Identifier
32641315
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.
Results Reference
background
PubMed Identifier
29099618
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.
Results Reference
background
PubMed Identifier
17908868
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.
Results Reference
background
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Injections of SVF in Ankle Osteoarthritis
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