Osteoarthritis
Conditions
Interventions
Personalized TKA group (Personalized TKA group will receive customized prostheses):None
Conventional TKA group (Conventional TKA group will receive standard commercial implants.):None
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the TKA (Total Knee Arthroplasty) study: 1) Patients diagnosed with end-stage knee joint diseases, including but not limited to degenerative osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory joint diseases; or those requiring correction of deformities, revision after failure of partial knee arthroplasty, or treatment of fractures not manageable by other techniques, and thus indicated for total knee arthroplasty. 2) Age between 50 and 80 years (inclusive). 3) The subject or their legal guardian is willing and able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1)History of prior surgical procedures on the affected knee. 2)Severe knee deformities (varus >15° or valgus >20°), or knee joint instability. 3)Severe flexion contracture deformity (flexion contracture >25°). 4)Undergoing revision total knee arthroplasty. 5)Diagnosis of rheumatoid arthritis. 6)Body Mass Index (BMI) >35. 7)Neuromuscular dysfunction (e.g., paralysis, myolysis, or muscle weakness) that may lead to postoperative knee instability or abnormal gait. 8)Women who are pregnant or breastfeeding. 9)Any underlying medical condition that, in the opinion of the investigator, places the subject at an unacceptable risk, including but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal disorders; or any severe progressive or uncontrolled disease or psychiatric condition that may interfere with compliance. 10)Ongoing infection with HIV, hepatitis B or C, or a history of these infections. 11)Evidence of progressive infection or malignancy confirmed by chest X-ray, CT, or MRI within 12 weeks prior to screening and assessed by a qualified physician. 12)Active systemic infection (excluding common cold) or other regularly recurring infections within the past two weeks. 13)History of chronic or recurrent infectious diseases, or positive tuberculosis screening. Subjects may participate if comprehensive evaluation within 12 weeks confirms no active TB; latent TB must be treated per local guidelines prior to baseline. 14)History of lymphoproliferative disease, or any known malignancy, or any malignancy in any organ system within the past five years (except treated Bowen’s disease, basal cell carcinoma, actinic keratosis, excised carcinoma in situ of the cervix, or non-invasive colonic polyps without recurrence in the past 12 weeks). 15)Coexisting medical problems including but not limited to: uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 95 mmHg); congestive heart failure (NYHA Class III or IV); serum creatinine >2.0 mg/dL (176.8 µmol/L); WBC <2500/µL, platelets <100000/µL, neutrophils <1500/µL, hemoglobin <8.5 g/dL; alcohol or drug abuse within 6 months or current evidence of abuse; mental incompetence or inability to understand study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score (KSS);Surgical Complication Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale Pain Score (VAS);Functional Improvement;Prosthesis Positioning and Alignment; | — |
Countries
China
Contacts
Public ContactJiakuo Yu
Orthopaedic and Sports Medicine Centerl, Beijing Tsinghua Changgung Hospital, Tsinghua University, China
Outcome results
None listed