Knee osteoarthritis
Conditions
Interventions
test group:Semi-individualized total knee arthroplast
Control group:Zimmer standard prosthesis total knee replacement
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Various end-stage knee joint diseases such as degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease, as well as deformity correction, reconstruction after failure of some knee joint prostheses, which cannot be treated by other techniques fractures, etc., total knee prosthesis replacement is required; 2. Aged 50 to 80 years; 3. The subjects or guardians are willing and able to sign the informed consent; 4. Only if the above 3 items are met at the same time will be included in the TKA surgery study.
Exclusion criteria
Exclusion criteria: 1. History of previous knee surgery; 2. Severe knee deformity (varus greater than 15° or valgus greater than 20°) or knee instability; 3. Severe flexion contracture deformity (flexion contracture > 25°); 4. Perform total knee joint revision and replacement surgery; 5. Rheumatoid arthritis; 6. Body mass index (BMI) > 35; 7. Patients with neuromuscular insufficiency (eg: paralysis, myolysis or muscle weakness) can cause postoperative knee instability or abnormal gait; 8. Pregnant or lactating women; 9. Suffering from an underlying medical condition (including but not limited to metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal) that, in the opinion of the investigator, the patient is at unacceptable risk; Severely progressive or uncontrolled disease that is not suitable for the trial or puts it at high risk, including any medical or psychiatric condition that the investigator believes will prevent the subject from following the protocol or completing the study according to the protocol; 10. Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or C, or a history of the corresponding disease; 11. Suffering from progressive infection or malignant disease, can produce chest X-ray, computed tomography (CT scan) or MRI evidence within 12 weeks before screening, and it has been confirmed by qualified physician evaluation; 12. Active systemic infection (except colds) within the previous two weeks or any other infection that recurs regularly; 13. History of chronic or recurrent infectious diseases, or evidence of positive tuberculosis infection at screening. Subjects with positive or inconclusive results were eligible to participate in the study if they had undergone a comprehensive tuberculosis test (as per local practice/guidelines) within the 12 weeks prior to baseline and were ultimately confirmed to have no evidence of active tuberculosis. If latent TB is confirmed, treatment must be initiated and maintained prior to baseline in accordance with local or national guidelines; 14. History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years (Bowen's disease, basal cell carcinoma, or actinic keratosis after treatment with no evidence of recurrence within the past 12 weeks disease; except for cervical carcinoma in situ that has been resected or non-invasive malignant colon polyps); 15. Concurrent medical problems, including but not limited to the following: (1) Uncontrolled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 95 mmHg), congestive heart failure (New York Heart Association status class III or IV); (2) Subjects whose serum creatinine level exceeds 2.0 mg/dl (176.8 µmol/L); (3) Total white blood cell (WBC) count at screening <2500/µL, or platelets <100000/µL or neutrophils <1500/µL or hemoglobin <8.5 g/dL; (4) A history of alcohol or drug abuse or evidence of ongoing abuse within six months prior to baseline; 16. The patient is mentally incapable or unable to understand the requirements of participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower limb force line;Knee prosthesis position;Clinical symptoms;gait; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactYu Jiakuo
Peking University Third Hospital
Outcome results
None listed