Comparison of Efficacy and Safety of Microfracture and Modified Microfracture (NCT02539030) | Clinical Trial Compass
UnknownPhase 4
Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
South Korea100 participantsStarted 2013-02
Plain-language summary
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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.
Who can participate
Age range15 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- 1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) 2. Knee osteoarthritis patients whose Kellgren-Lawrence Grading Scale score is lower than 3 (patients who received simultaneous or previous correction will be excluded).
3\. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment 4. Patients who were 15 years old or older 5. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
Exclusion Criteria:
* 1\. If patients or their families suffer from or have ever suffered from an autoimmune disease.
2\. Patients who have ever suffered an anaphylactic reaction. 3. Patients who have ever suffered hypersensitivity to an implant. 4. Patients with a history of allergy to porcine or bovine protein. 5. Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
6\. Subjects with autoimmune disease related arthritis. 7. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy. 8. Subjects with tumors. 9. Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
10\. Subjects who are diabetic. (Exception: if the possibility of CartiFill™ …