Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-02 @ 10:35 AM
Study NCT ID:
NCT07003035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
Sponsor:
YujiakuoTHU
Organization:
Study Overview
Official Title:
A Multi-Center Prospective Cohort Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
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:
The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.
Detailed Description:
This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized TKA system.
This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.
This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: