Men and Women With Different Designs and Semi-individual Total Knee Replacement
NCT04976400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600
Last updated 2021-07-26
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.
Conditions
- Arthroplasty, Replacement, Knee
Interventions
- 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).
Sponsors & Collaborators
-
Guizhou Orthopedics Hospital
collaborator UNKNOWN -
Shenyang Orthopedic Hospital
collaborator OTHER -
West China Hospital
collaborator OTHER -
Xi'an Honghui Hospital
collaborator OTHER -
First Affiliated Hospital of Chongqing Medical University
collaborator OTHER -
The Affiliated Hospital Of Guizhou Medical University
collaborator OTHER -
Jining Medical University
collaborator OTHER -
Northern Jiangsu People's Hospital
collaborator OTHER -
Inner Mongolia People's Hospital
collaborator OTHER -
Shenzhen Pingle Orthopedics Hospital
collaborator UNKNOWN -
Peking University Third Hospital
lead OTHER
Principal Investigators
-
Jiakuo Yu, Doctor · Peking University Third Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2025-01-01
- Completion
- 2025-01-01
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