Osteoarthritis
Conditions
Interventions
Conventional TKA Group (Total knee arthroplasty using conventional imported Zimmer prosthesis (Zimmer, Warsaw, IN, USA)):None
Semi-personalized TKA Group (Total knee arthroplasty using gender-specific prosthesis designed from Chinese anatomical parameter optimization):None
Personalized TKA Group (Total knee arthroplasty using fully customized 3D-printed prosthesis based on individual anatomical data):None
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with end-stage knee joint diseases such as degenerative osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthropathy, or those requiring total knee arthroplasty (TKA) due to deformity correction, failed partial prostheses, or fractures not amenable to other treatments; 2) Age between 50 and 80 years (inclusive); 3)The patient or their legal guardian is willing and able to sign the informed consent form. All three criteria must be met for inclusion in the study.
Exclusion criteria
Exclusion criteria: 1) History of previous knee surgery; 2) Severe knee deformities (varus >15° or valgus >20°) or instability; 3) Severe flexion contracture deformity (flexion contracture >25°); 4) Undergoing revision TKA surgery; 5) Diagnosis of rheumatoid arthritis (RA); 6) Body mass index (BMI) >35; 7) Neuromuscular disorders (e.g., paralysis, rhabdomyolysis, or muscle weakness) that may lead to joint instability or abnormal gait; 8) Pregnant or lactating women; 9) Any underlying medical conditions deemed by the investigator to pose unacceptable risk, including but not limited to metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal diseases; or any other uncontrolled or progressive disease that may interfere with study participation; 10) Known history or current infection with HIV, hepatitis B, or hepatitis C; 11) Active infections or malignancies with radiographic evidence (X-ray, CT, or MRI) within the past 12 weeks confirmed by a qualified physician; 12) Systemic active infections within the past 2 weeks (excluding common cold) or recurrent infections; 13) History of chronic or recurrent infectious diseases, or positive tuberculosis screening. Patients testing positive or uncertain for latent TB must have completed a full screening and treatment plan in accordance with local guidelines within 12 weeks prior to baseline; 14) History of lymphoproliferative disorders, known malignancy, or malignancy within the past 5 years (except treated Bowen’s disease, basal cell carcinoma, actinic keratosis, cervical carcinoma in situ, or non-invasive colon polyps); 15) Coexisting medical conditions, including but not limited to: • Uncontrolled hypertension (systolic >= 160 mmHg and/or diastolic >= 95 mmHg) • Congestive heart failure (NYHA Class III or IV) • Serum creatinine >2.0 mg/dL (176.8 µmol/L) • Total WBC <2500/µL, platelets <100,000/µL, neutrophils <1500/µL, or hemoglobin <8.5 g/dL • History of alcohol or substance abuse within 6 months prior to screening • Psychiatric or cognitive disorders affecting the ability to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score (KSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Severity;Functional Improvement;Prosthesis Positioning and Alignment;Surgical Complication Rate; | — |
Countries
China
Contacts
Public ContactJiakuo Yu
Orthopaedic and Sports Medicine Centerl, Beijing Tsinghua Changgung Hospital, Tsinghua University, China
Outcome results
None listed