Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 3:03 AM
Study NCT ID:
NCT04927104
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2021-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study on Safety of PEEK Knee Prosthesis
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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.
Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: