Therapeutic impact of Adipose-derived Stromal Vascular Fraction And Platelet-rich plasma on non-operative treatment of osteochondral lesions of the talus: A Randomized Controlled Trial
Comparing the effect of stromal vascular fraction and Platelet-rich plasma on talus osteochondritis
Design
A controlled, two-parallel, randomized, unblinded phase 2 clinical trial on 40 patients. The NIH site was used for randomization
Settings and conduct
Patients are enrolled in the study at Akhtar Hospital and undergo diagnostic and therapeutic interventions at Shahada Tajrish Hospital, which include MRI and CT scan. Then the questionnaires are completed and they are subjected to intra-articular injection in the same center. Blinding is not possible due to the different method in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria in the study:
The symptoms have been continuous for at least 3 months, and has not responded to conservative treatment
Exclusion criteria from the study:
Surgery or intra-articular injection
Intervention groups
The intervention group of talus osteochondritis patients receiving svf( stromal vascular fraction)
The intervention group of talus osteochondritis patients receiving PRP (Platelet-rich plasma)
Main outcome variables
American Orthopedic Foot and Ankle Society scores, visual analog scale, Ankle Osteoarthritis Scale, lesion diameter and lesion grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231212060345N1
Registration date:2024-02-04, 1402/11/15
Registration timing:registered_while_recruiting
Last update:2024-02-04, 1402/11/15
Update count:0
Registration date
2024-02-04, 1402/11/15
Registrant information
Name
Sina Hajiaghajani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 6712
Email address
sinaaghajani1379@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic impact of Adipose-derived Stromal Vascular Fraction And Platelet-rich plasma on non-operative treatment of osteochondral lesions of the talus: A Randomized Controlled Trial
Public title
The effect of vascular stromal cells and platelet-rich plasma in the treatment of osteochondral lesions of the talus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The symptoms have been continuous for at least 3 months and have not responded to conservative treatment
age 18-70 years
Patients with grade I, II Bernadet and Harry classification lesions
CT SCAN and MRI confirm the diagnosis and no other pathology is involved
The patient has the ability to understand the explanations and registers her verbal and written wishes in the informed consent form
Exclusion criteria:
presence of inflammatory arthritis such as rheumatoid arthritis, other systemic diseases such as diabetes and systemic inflammatory diseases; Systemic infection
History of cardiovascular disease such as previous stroke or heart failure or coagulation problem such as disturbed PT, PTT, INR
Any surgery or intra-articular injection
Drug users or alcoholics
Pregnancy or breastfeeding
Severe weight loss in such a way that liposuction is not possible.
Abdominal hernia
The presence of loose bodies, osteoarthritic changes, impingement spurs, or other pathology
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple, the randomization is individual, there is no stratified randomization, randomization with the NIH site tool, and the final Excel is prepared for randomization. Is.
After entering the study according to the conditions mainly mentioned above, it is determined what intervention is performed for each patient based on a predetermined chain in Excel. For example, row 1 T is equivalent to the intervention group or row 2 C is equivalent to the control group.
The patients are chained according to the order of referral, the first patient in the first row, the second patient in the second row, and so on
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Committee of Research Ethics of Dermatology Research Center - Shahid Beheshti Universi
Street address
Tehran - Quds town (west) - between South Flamak and Zarafshan, Simai Iran St. - Central Headquarters of Ministry of Health, Treatment and Medical Education, Block A, 13th floor
Osteochondritis dissecans of ankle and joints of foot
Primary outcomes
1
Description
diameter of Lesion
Timepoint
before entering the study - six months later
Method of measurement
CT scan
Secondary outcomes
1
Description
function of ankle
Timepoint
before entering the study - one month later - three months later - six months later
Method of measurement
American Orthopedic Foot and Ankle Society questionnaire
2
Description
pain
Timepoint
before entering the study - one month later - three months later - six months later
Method of measurement
visual analog scale
3
Description
osteoarthritis changes
Timepoint
before entering the study - one month later - three months later - six months later
Method of measurement
Ankle osteoarthritis scale questionnaire
4
Description
Lesion grade
Timepoint
before entering the study - six months later
Method of measurement
CT scan - Berndet and harty classification
Intervention groups
1
Description
Intervention group: intra-articular injection of vascular stromal cells taken from fat, necessary equipment, svf extraction kit-syringe, SVF preparation: about 100 mL of adipose tissue is taken sterilely through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat is prepared for injection into the joint. The injection volume is 4-5 cc. The quantity and viability of the cells is done through direct observation under the neobar slide. After the injection, the patient must not apply weight for 24 hours The leg should be restrained (walk with a cane) and only paracetamol is allowed to be used for pain control. After a week, the patients will be contacted and questions will be asked about possible side effects.
Category
Treatment - Other
2
Description
Control group: Intervention group: intra-articular injection of platelet-rich plasma taken from peripheral blood, necessary equipment for PRP extraction kit-syringe, first blood is taken from a peripheral vein, then PRP is extracted from it with a centrifuge and injected for one time after injecting the patient until For 24 hours, he must refrain from putting weight on his leg (walk with a cane) and to control pain, only paracetamol is allowed to be used. After one week, patients will be contacted and questions will be asked about possible side effects.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Ali Asghar Alamian
Street address
Tehran - Shariati St. - Paul Rumi St. - Sharifi Menesh St. - Azar Dead End - Akhtar Orthopedic Center
City
tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Web page address
https://amc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Reza Rabati
Street address
Tehran<, Skin Research Center, Shahid Beheshti Medical University,Shohada E Tajrish, ghods Sq, Shahrdari St
City
tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 2274 1507
Fax
+98 21 2274 4393
Email
src@sbmu.ac.ir
Web page address
https://src.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?