A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System

Sponsor
YujiakuoTHU
Study ID
NCT07003035
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.

Key Dates

First listed
Jun 4, 2025
Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Cohort 1
    A total of 80 participants will be enrolled, with 40 receiving personalized total knee arthroplasty and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.

Primary Outcome Measure

Knee Society Score (KSS) [ Time Frame: At baseline, 6 months, and 12 months post-surgery ]

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