This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.
This study was an open-trial study. One hundred subjects participated in it. The study was explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study was checked, and they were randomized either into the simple microfracture group or the modified microfracture group using collagen based on a centrally controlled randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital six times\*, including for screening. At each visit, the subjects underwent an examination with doctors, a blood test, an X-ray procedure, an MRI, an observation with the naked eyes, and arthroscopy to evaluate the safety and efficacy of the procedure. (\*If the screening date overlaps with the procedure date, the number of his or her visits would be five.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
simple microfracture
add collagen when doing microfracture
Daejeon Sun hospital
Daejeon, Daejeon, South Korea
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
The Catholic University of Korea Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
100mmVAS(Visual Analogue Scale)
It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.
Time frame: 12 month after surgery
change of 100 mmVAS (Visual Analogue Scale)
The difference between the VAS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the VAS scores obtained at the follow-ups (3, 6, and 24 months after surgery) will be compared.
Time frame: screening, 3, 6, 12 and 24 months after surgery
change of Knee injury and osteoarthritis outcome (KOOS)
The difference between the KOOS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the KOOS scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.
Time frame: screening, 6, 12 and 24 months after surgery
change of International Knee Documentation Committee (IKDC)
The difference between the IKDC scores of the affected knee at the screening and 12 months after the surgery in the investigation group will be compared to that in the control group. The differences in the IKDC scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.
Time frame: screening, 6, 12 and 24 months after surgery
the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART
The results obtained 12 months after the surgery on the affected knee in the investigational and control groups will be described. mMOCART will be obtained, and the difference will be assessed. \* Depending on the MRI equipment, if in-house imaging is not possible, it may be done at the other hospitals conducting the research.
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Inha University Hospital
Incheon, Incheon, South Korea
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul, South Korea
Inje University Seoul Paik Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
...and 2 more locations
Time frame: 12 months after surgery