NCT04950348

Clinical Trials of Prosthesis and Surgery Guide System

Preliminary Exploration of Clinical Trials of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 51 Years – 79 Years
• Healthy volunteers: Accepted

Summary

1. The subject continues the research of Professor JiaKuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee replacement artificial joint prostheses and the verification of animal and human cadavers. It is planned to carry out the femoral condyle prosthesis of personalized total knee replacement prosthesis. Clinical trials are carried out on the body, tibial tray prosthesis and meniscus prosthesis; at the same time, in order to achieve personalized precision surgery, the clinical trial verification is carried out on the placement of personalized surgical guides that match the personalized artificial joints. 2. In the clinical verification study, the research team will summarize the role of personalized artificial joints for total knee replacement and personalized implant surgical guides in the precise and minimally invasive treatment of knee joint diseases.

Detailed description

This study aims to evaluate the safety and effectiveness of the femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of the personalized total knee replacement system; to verify the clinical feasibility and safety of the personalized surgical guide, as a personalized total knee replacement The clinical application of the prosthesis and its guide lays the foundation, including: 2.1 Evaluate the advantages of personalized total knee replacement surgery in osteotomy methods, evaluate the impact of anatomical osteotomy methods on intraoperative and postoperative effects and early and long-term clinical effects. 2.2 By measuring the amount of osteotomy in personalized total knee replacement surgery, evaluate the impact of a smaller and reasonable amount of osteotomy on the patient's early and long-term clinical results. 2.3 Verify the clinical effect of personalized total knee replacement prosthesis, and provide the basis for its clinical promotion and application.

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: 2021-05-01
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2021-07-06
• Last updated: 2021-07-06

Locations

1 site across 1 country: China