NCT04976400

Men and Women With Different Designs and Semi-individual Total Knee Replacement

Research on Clinical Solutions of Artificial Joints for Men and Women With Different Designs and Semi-individual Total Knee Replacement：A Prospective Cohort Clinical Trial Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including: 1. Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method. 2. To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy. 3. Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.

Detailed description

Patients meeting the inclusion and exclusion criteria were divided into the experimental group and the control group according to the patient's wishes. Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. The control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
PROCEDURE	semi-individualized total knee replacement treatment with a gender-specific design	Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.
PROCEDURE	Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)	Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2021-07-26
• Last updated: 2021-07-26