The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are: Does the treatment help the knee work better and lower pain more than the standard surgery? Is the treatment safe and does it help grow stronger new cartilage? Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery. Participants will: Have a surgery to treat their knee cartilage damage. Visit the clinic for check-ups to see how well their knee moves. Take imaging tests, like an MRI, so researchers can look at the new cartilage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.
This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.
Yeungnam University Medical Center
Daegu, Daegu, South Korea
RECRUITINGCatholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGHanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
RECRUITINGChung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
RECRUITINGBundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGCatholic University of Korea Incheon St. Mary's Hospital
Goyang, Incheon, South Korea
NOT_YET_RECRUITINGGachon University Gil Medical Center
Incheon, Incheon, South Korea
RECRUITINGInha University Hospital
Incheon, Incheon, South Korea
RECRUITINGJeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
RECRUITINGChonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
RECRUITING...and 3 more locations
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year
Time frame: Baseline to 12 months
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months
Time frame: Baseline, 3 months, 6 months, and 9 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months
Time frame: Baseline, 6 months, and 12 months
Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months
Time frame: Change from baseline in IKDC
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