- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04927104
Exploratory Study on Safety of PEEK Knee Prosthesis
Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai, China, 200127
- Renji Hospital,Shanghai Jiao Tong University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PEEK Knee Prosthesis
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety measures at 12 months after surgery
Time Frame: 12 months
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The expected incidence of device-related complications within 12 months after surgery is 0.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
X-ray examination
Time Frame: At 3 and 12 months postoperatively
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At 3 and 12 months postoperatively, the prosthesis observed for clear lines and signs of loosening.
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At 3 and 12 months postoperatively
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CT
Time Frame: one week and 12 months after surgery
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The wear of the prosthesis measured one week and 12 months after surgery.
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one week and 12 months after surgery
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MRI
Time Frame: 3 and 12 months after surgery
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Inflammation and effusion around the prosthesis assessed 3 and 12 months after surgery.
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3 and 12 months after surgery
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Hematological examination indexes 3 and 12 months after surgery
Time Frame: 3 and 12 months after surgery
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Including: blood routine, liver and kidney function, erythrocyte sedimentation rate, C-reactive protein
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3 and 12 months after surgery
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Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively
Time Frame: 3,6, 12 months after surgery
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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.
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3,6, 12 months after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of other complications
Time Frame: 3,6, 12 months after surgery
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These include infection, knee stiffness, venous thrombosis in the lower extremities, and pulmonary embolism.
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3,6, 12 months after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: You Wang, MD, Renji Hospital
- Principal Investigator: Teng Long, MD, Renji Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSSZZK2020001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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