A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis
NCT ID: NCT06990594
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2025-06-01
2027-12-31
Brief Summary
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Detailed Description
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This is a prospective cohort and controlled study involving 120 patients, including 40 in the experimental group receiving personalized TKA, 40 receiving semi-personalized TKA, and 40 in the control group receiving conventional TKA. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
A total of 120 participants will be enrolled, with 40 receiving total knee arthroplasty (TKA) using a personalized prosthesis, 40 receiving semi-personalized TKA, and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
10. Active or recent severe infections or malignancy.
11. History of drug or alcohol abuse in the past six months.
50 Years
80 Years
ALL
No
Sponsors
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Peking University Shougang Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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YujiakuoTHU
Prof.
Locations
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Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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25034-0-02
Identifier Type: -
Identifier Source: org_study_id
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