Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with knee pain from cartilage damage or arthritis on the inner side of the knee who will have CARTISTEM stem cell implantation. It compares two ways of drilling small holes in the bone under the cartilage.

Életkor

19 years or older

Nem

All sexes

A betegség stádiuma

Cartilage damage or arthritis on the inner (medial) side of the knee, confirmed by imaging and judged to be the main cause of symptoms. Grade IV (Kellgren-Lawrence) osteoarthritis cannot join.

Korábbi kezelés

Knee pain for at least 3 months despite conservative treatment, such as medication or physical therapy. CARTISTEM implantation must already be decided. No knee cartilage surgery within 1 year before screening.

A részvétel fő kizáró okai

• Loose knee ligaments that need ligament surgery at the same time
• Bow-legged alignment of 5 degrees or more, unless corrected by high tibial osteotomy (a bone-realigning surgery) at the same time
• Autoimmune or inflammatory arthritis, such as rheumatoid arthritis
• Unable to have an MRI scan
• Body mass index of 35 kg/m² or more

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• 2-mm subchondral drillingA vizsgált kezelés

  Subchondral drilling with a 2-mm drill alone, followed by CARTISTEM implantation. High tibial osteotomy may be performed when needed for alignment correction.

• Sequential 4-mm and 2-mm subchondral drillingMár használt kezelés, összehasonlításként

  Sequential subchondral drilling with 4-mm and 2-mm drills, followed by the same CARTISTEM preparation and implantation. High tibial osteotomy may be performed when needed.