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

Launched by YUJIAKUOTHU · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new kind of knee surgery called personalized total knee arthroplasty (TKA). The goal is to find out if this personalized approach leads to better results compared to the standard TKA procedure for patients with severe knee arthritis. Researchers will be comparing how well patients recover after surgery, how many complications they experience, and the overall costs involved. This study is planned to take place at multiple medical centers, but it has not started recruiting participants yet.

To be eligible for this trial, participants should be between 50 and 80 years old and diagnosed with severe knee arthritis that requires surgery. However, there are some important criteria that would exclude individuals, such as having had previous knee surgery, certain severe knee deformities, or specific health conditions that could complicate the surgery. If you qualify and choose to participate, you can expect to receive personalized care tailored to your knee needs, and your progress will be closely monitored throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 50-80 years.
• • 2. Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
• • 3. Willing and able to provide informed consent.
• Exclusion Criteria:
• • 1. History of prior knee surgery or knee replacement.
• • 2. Severe knee deformity (valgus \>20° or varus \>15°) or instability.
• • 3. Severe contracture (\>25° flexion contracture).
• • 4. Undergoing total knee revision surgery.
• • 5. Rheumatoid arthritis diagnosis.
• • 6. BMI \>35.
• • 7. Neuromuscular disorders affecting knee stability or gait.
• • 8. Pregnancy or lactation.
• • 9. Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
• • 10. Active or recent severe infections or malignancy.
• • 11. History of drug or alcohol abuse in the past six months.