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 in patients with cartilage defects in their ankles.
This study was an open-trial study. Sixty 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 randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects underwent an examination with doctors and MRI to evaluate the efficacy of the procedure. (\*If the subject began the first visit on the screening date, the total number of his or her visits was four.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
simple microfracture of ankle
add collagen when doing microfracture
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGEulji general Hospital
Seoul, Seoul, South Korea
RECRUITINGHallym University Medical Center-Kangnam Sacred Heart Hospital
Seoul, Seoul, South Korea
RECRUITING100mmVAS(visual analogue scale) score
The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.
Time frame: 12 months after the surgery
Change score of 100mmVAS(visual analogue scale)
The difference in the 100mmVAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the 100mmVAS after 6, and 24 months.
Time frame: Screening, 6, 12, and 24months after surgery
Change of Satisfaction evaluation by patients
The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.
Time frame: Screening, 6, 12, and 24months after surgery
Change of AOFAS(American orthopaedic foot & ankle society) Score
The difference in the AOFAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the AOFAS after 6, and 24 months.
Time frame: Screening, 6, 12, and 24months after surgery
Change of Hannover Score
The difference in the Hannover Score on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the Hannover Score after 6, and 24 months.
Time frame: Screening, 6, 12, and 24months after surgery
Change of Satisfaction evaluation by physician in charge
The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.
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Time frame: Screening, 6, 12, and 24months after surgery
Change results of Arthroscopy (ICRS(International Cartilage Repair Society))
The conditions of the affected ankle before and 24 months after the surgery were recorded and the ICRS's were evaluated in the study and control group. \* Arthroscopy was performed in up to 10 subjects who signed the consent form.
Time frame: before and 24 months after the surgery
the result of MRI(mMOCART)
The conditions of the affected ankle 24 months after the surgery were recorded and the mMOCART were evaluated in the study and control group.
Time frame: 24 months after the surgery