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| Name | Class |
|---|---|
| Suzhou SinoMed Biomaterials Co., Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEK Knee Prosthesis | Experimental | In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEK Knee Prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures at 12 months after surgery | The expected incidence of device-related complications within 12 months after surgery is 0. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| X-ray examination | At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening. | At 3 and 12 months postoperatively |
| CT | The wear of the prosthesis measured one week and 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of other complications | These include infection, knee stiffness, venous thrombosis in the lower extremities, and pulmonary embolism. | 3,6, 12 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| You Wang, MD | RenJi Hospital | Principal Investigator |
| Teng Long, MD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital,Shanghai Jiao Tong University School of Medicine | Shanghai | 200127 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2021 | Jul 19, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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| one week and 12 months after surgery |
| MRI | Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery. | 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 | 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. | 3,6, 12 months after surgery |
| D012216 |
| Rheumatic Diseases |