Clinical Trials of Prosthesis & Surgery Guide System

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04950348
Study type	Interventional
Source	Peking University Third Hospital
Contact	Fu-zhen Yuan
Phone	18511440808
Email	yuanfuzhen2016@163.com
Status	Recruiting
Phase	N/A
Start date	May 1, 2021
Completion date	December 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trials of Prosthesis and Surgery Guide System

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms