JPRN-jRCT2080224161
Completed
未知
An exploratory clinical trial to evaluate the efficacy and safety of the CCI Kit in patients with knee joint cartilage defects.
Interstem CO .,Ltd0 sites36 target enrollmentNovember 26, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Traumatic cartilage defect of the knee joint and osteochondritis dissecans
- Sponsor
- Interstem CO .,Ltd
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Patients diagnosed with traumatic cartilage defect of the knee joint and osteochondritis dissecans
- •2\)Patients applying microfractures
- •3\)Patients with clinical symptoms in the knee joint
- •4\)Patients with KOOS 5 of 70 or less at screening
- •5\)Patients with a cartilage defect area from 2 cm2 to 9 cm2
Exclusion Criteria
- •1\)Patients diagnosed with osteoarthritis and patients with Kellgren\-Lawrence classification stage 2 or higher
- •2\)Patients with inflammatory arthritis associated with autoimmune diseases such as rheumatoid arthritis
- •3\)Patients with cartilage defect in both knee joints
- •4\)Patients with multiple cartilage defect
- •5\)Patients with a bone defect with a depth of 8 mm or more at the cartilage defect site
- •6\)Patients who have a history of surgery for adjustment of joint alignment or who need it
Outcomes
Primary Outcomes
Not specified
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