Status:
NOT_YET_RECRUITING
A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
Lead Sponsor:
YujiakuoTHU
Collaborating Sponsors:
Peking University Shougang Hospital
Beijing Chao Yang Hospital
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-80 years
Brief Summary
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...
Detailed Description
This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the...
Eligibility Criteria
Inclusion
- Patients aged 50-80 years.
- Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
- Willing and able to provide informed consent.
Exclusion
- History of prior knee surgery or knee replacement.
- Severe knee deformity (valgus \>20° or varus \>15°) or instability.
- Severe contracture (\>25° flexion contracture).
- Undergoing total knee revision surgery.
- Rheumatoid arthritis diagnosis.
- BMI \>35.
- Neuromuscular disorders affecting knee stability or gait.
- Pregnancy or lactation.
- Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
- Active or recent severe infections or malignancy.
- History of drug or alcohol abuse in the past six months.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07003035
Start Date
June 1 2025
End Date
December 31 2027
Last Update
June 4 2025
Active Locations (1)
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1
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China, 102218