2-mm subchondral drilling vs sequential 4-mm and 2-mm drilling during CARTISTEM implantation for knee cartilage defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, prospective study at Severance Hospital, Yonsei University, compares two subchondral drilling techniques performed during CARTISTEM implantation for symptomatic medial-compartment knee cartilage defects. Participants are assigned 1:1 to either a single 2-mm drill or sequential 4-mm followed by 2-mm drilling, with CARTISTEM cells and hydrogel used in both groups. The primary outcome is the IKDC Subjective Knee Evaluation at 12 months to determine non-inferiority, with secondary measures including pain, function scores, MRI and radiographic findings, and potential second-look arthroscopy if high tibial osteotomy is performed. Recruitment targets 60 adults and follows them for 12 months post-surgery, with overall study duration up to three years from approval.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 19 years or older.
2. Knee pain for at least 3 months despite conservative treatment, including medication or physical therapy.
3. Medial-compartment knee arthritis or articular cartilage defects judged to be the main cause of symptoms.
4. Imaging-confirmed medial-compartment cartilage defects for which CARTISTEM implantation has been decided.
5. Voluntary written informed consent by the participant or legally authorized representative after understanding the study.

Exclusion Criteria:

1. Surgery for knee cartilage injury within 1 year before screening.
2. Ligament instability requiring simultaneous ligament surgery.
3. Kellgren-Lawrence grade IV osteoarthritis on weight-bearing anteroposterior knee radiographs.
4. Mechanical-axis varus deformity of 5 degrees or greater, unless corrected by simultaneous high tibial osteotomy.
5. Autoimmune or inflammatory arthritis, including rheumatoid arthritis.
6. Inability to undergo MRI.
7. Body mass index of 35 kg/m² or greater.
8. Inability to adequately understand the study explanation, including illiteracy or a language barrier.
9. Age younger than 19 years.

Where it's running

• Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sung-Hwan Kim, Professor
• Email: orthohwan@gmail.com
• Phone: +82-2-2228-2180

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.