NCT04963491

Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

A Prospective Cohort Clinical Trial Study of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 51 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The subject is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides.

Detailed description

The subject continues the research of Professor Jia-kuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee arthroplasty (TKA) prostheses and the verification of animal and human cadavers. It is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides. In the clinical validation study, the research team will summarize the role of personalized TKA prostheses and personalized TKA cutting guides in the precise and minimally invasive treatment of knee osteoarthritis.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Personalized TKA prosthesis	TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
DEVICE	Zimmer NexGen prostheses	Commercial products used on a large scale

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-07-15
• Last updated: 2021-07-15