In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
According to the involved person's biomedical research ethics review method "(national health and family planning commission (11)) and the medical and health institutions to carry out the researchers launched a clinical research management method" (draft) on request, for national key development plan required for research and development production of PEEK knee prosthesis for clinical trials. In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up. Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
After subjects drop out of the study for any reason, the researchers can perform revision surgery using the prosthetic joint that is now routinely used.
Renji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, China
Safety measures at 12 months after surgery
The expected incidence of device-related complications within 12 months after surgery is 0.
Time frame: 12 months
X-ray examination
At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening.
Time frame: At 3 and 12 months postoperatively
CT
The wear of the prosthesis measured one week and 12 months after surgery.
Time frame: one week and 12 months after surgery
MRI
Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery.
Time frame: 3 and 12 months after surgery
Hematological examination indexes 3 and 12 months after surgery
Including: blood routine, liver and kidney function, erythrocyte sedimentation rate, C-reactive protein
Time frame: 3 and 12 months after surgery
Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
The full score of KSS is 100, above 85 is excellent, 70-84 is good, 60-69 is acceptable, and less than 60 is poor. Calculate the proportion of excellent and good grades.
Time frame: 3,6, 12 months after surgery
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