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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976400 on ClinicalTrials.gov