Exploratory Study on Safety of PEEK Knee Prosthesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis

Conditions
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Rheumatoid Arthritis of Knee, Osteoarthritis of the Knee

Intervention / Treatment
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* Device: PEEK Knee Prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery. Subjects skeletal maturity. Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity. The diseased side knee appropriate for primary total knee arthroplasty . Subjects or guardian is willing and able to sign the informed consent form . Exclusion Criteria: Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency. Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) . Alcoholics, drug addicts and drug abusers. Subjects with severe diabetes (fasting blood glucose > 10mmol/L) Body Mass Index, BMI>35. Female subjects who are pregnant or lactating. Subjects have disease limited their participation in the investigation or have an existing condition that would compromise their participation and follow-up in this clinical investigation. In the month before inclusion, subjects who participated in clinical studies of other drugs, biological agents or medical devices and failed to meet the main research endpoints. Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK Knee Prosthesis<br>In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis. | Device: PEEK Knee Prosthesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, PEEK Knee Prosthesis