The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
\*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1. Procedure: Microfracture 2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)
\*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1\. Procedure: Microfracture
Kyunghee University Medical Center
Seoul, Dongdaemun-gu, South Korea
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
ICRS-Cartilage Repair Assessment Total Score
Arthroscopic evaluation of articular cartilage repair : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury
Time frame: Week 48
ICRS-Cartilage Repair Assessment Overall Grade
The grades range from 1(normal) to 4 (severely abnormal) where lower grades indicate more complete repair
Time frame: Week 48
Improvement degree of Cartilage Repair by MRI
Changes in MOCART(Magnetic resonance Observation of Cartilage Repair Tissue) score : MOCART score is a 9-part and 29-item scoring system, also resulting in a find cartilage repair tissue score between 0 and 100 points. 100 points represent the best imaginable score
Time frame: Week 0 and 48
Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)
: FAOS consists in 42 items that cover 5 dimensions (symptoms, pain, activities of daily living, sport and recreation activities, and quality of life. Raw scores of each sub-scales results of the sum of each items. A normalized score (100 indicationg no symptoms and 0 indicating extreame sysmptoms) is calculated for each subscale
Time frame: Week 0, 24 and 48
Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)
: AOFAS consists in 9 items that can be divided into 3 sub-scales (pain, function and alignment). 100 points of 1 to 100 represent no symptoms or impairments
Time frame: Week 0, 24 and 48
Degree of Functional improvement in Tegner activity score
: Tegner activity represents the highest level of activity on scale of 0 to 10 that you are able to participate in currently . The higher values represent a better outcome
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Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
Inha University Hospital
Incheon, Jung-gu, South Korea
Time frame: Week 0, 24 and 48
Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)
: SF-36 comprises 36 items divided into two components of physical health and mental health. Higher scores between 0 and 100 represent better health status
Time frame: Week 0, 24 and 48
Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)
* VAS represents higher scores mean higher pain * 0 mm (no pain) and 100 mm (worst pain)
Time frame: Week 0, 24 and 48