A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Osteoarthritis. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (TKA) in osteoarthritis treatment. The study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional TKA in a multi-center, bidirectional cohort study.
Detailed description
This study aims to assess the performance of personalized, semi-personalized, and conventional total knee arthroplasty (TKA) procedures across different patient groups.
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.
Primary outcome measures
- Knee Society Score (KSS) [Time frame: At baseline, 6 months, and 12 months post-surgery]
Secondary outcome measures (4)
- Pain Severity [Time frame: At baseline, 6 months, and 12 months post-surgery]
- Functional Improvement [Time frame: At baseline, 6 months, and 12 months post-surgery.]
- Prosthesis Positioning and Alignment [Time frame: At baseline and 12 months post-surgery.]
- Surgical Complication Rate [Time frame: At 12 months post-surgery.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
- Active or recent severe infections or malignancy.
- History of drug or alcohol abuse in the past six months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Tsinghua Chang Gung Hospital — Beijing
Identifiers
NCT: NCT06990594 · 25034-0-02