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Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects
Sponsor: Yonsei University
Summary
This prospective, randomized study at Severance Hospital compares two subchondral drilling techniques during CARTISTEM implantation for symptomatic medial-compartment knee articular cartilage defects. Sixty participants will be allocated 1:1 to drilling with a 2-mm drill alone or sequential drilling with 4-mm and 2-mm drills. CARTISTEM preparation and implantation will be the same in both groups. High tibial osteotomy may be performed when needed to correct alignment. The primary endpoint is the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at 12 months after surgery. The study will assess non-inferiority of the 2-mm technique using a prespecified margin of 10.3 points. Secondary assessments include pain and knee function, MRI cartilage repair and subchondral bone findings, radiographic osteoarthritis and alignment, and second-look arthroscopy in participants undergoing plate removal after high tibial osteotomy.
Official title: Comparative Analysis of Clinical Outcomes According to Subchondral Bone Drilling Diameter in Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell (Cartistem®) Implantation for Knee Articular Cartilage Defects
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07-13
Completion Date
2029-02-19
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
2-mm subchondral drilling
Under general or spinal anesthesia, the cartilage defect is exposed and prepared. Subchondral holes are drilled with a 2-mm drill alone. Allogeneic umbilical cord blood-derived mesenchymal stem cells are mixed with sodium hyaluronate hydrogel, placed into the drilled holes, and applied over the defect. The same cell product preparation is used in both arms. High tibial osteotomy may precede implantation when indicated.
Sequential 4-mm and 2-mm subchondral drilling
Under general or spinal anesthesia, the cartilage defect is exposed and prepared. Subchondral holes are made using sequential 4-mm and 2-mm drilling. The same allogeneic umbilical cord blood-derived mesenchymal stem cell and sodium hyaluronate hydrogel preparation is implanted into the holes and over the defect. High tibial osteotomy may precede implantation when indicated.
Locations (1)
Yonsei University College of Medicine
Seoul, South Korea