Any diseases requiring primary unicompartmental knee arthroplasty
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with indications for unicompartmental knee arthroplasty. 2. Aged 18-80 years, no gender limit, bone devoloped. 3. Body mass index (BMI) 90° 5. Patients without arthroplasty on ipsilateral joints (hip, knee or ankle). 6. Patients with the ligaments of the knee in good condition. 7. Patients without systemic infection or local infection in the operative side. 8. Patients who voluntarily participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patiens with muti-compartmental arthritis (eg: rheumatoid arthritis or hemophiliac arthritis); or with bi-compartmental osteoarthritis. 2. Patients with severe degeneration of the patellofemoral joint, such as extensive ivory-like cartilage lesions in the patella and trochlear; patients with severe osteoporosis or bone defect which greatly affect prosthesis fixation; patients with expected unsatifactory results in lower leg alignment and joint stability after surgery; patients with hip disease and significant limitation of hip movement. 3. Patients with diseases that may jeopardize implant stability or surgical recovery (such as osteitis, neuropathic joint disease, vascular insufficiency, muscular dystrophy, or uncontrolled diabetes); patients who cannot comply with the follow-up and affect the scientific integrity of the trial 4. Patients who are immunosuppressed; or with autoimmune disease. 5. Patients with coagulation dysfunction that cannot be corrected by treatment. 6. Patiens wiht history of allergy to implant materials or surgical instruments. 7. Patients with neuromotor dysfunction which can affect skeletal muscle function (such as Parkinson's disease), or wiht mental illness and unable to cooperate or unwilling to cooperate. 8. Patients who are physically weak or cannot tolerate surgery due to other serious diseases. 9. Patients who are drug or alcohol abuser. 10. Lactating women; pregnant women; or patients who have pregnant planning during the experiment. 11. Patients who participated in others clinical studies of drugs or medical devices within 1 month before enrollment. 12. Other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The accurate rate of implant component position;Hip-knee-ankle angle, HKA;Oxford knee score, OKS;Vasual analogue scale pain score, VAS pain score;Knee range of motion, Knee ROM; | — |
Countries
China
Contacts
Second Affiliated Hospital of Xi 'an Jiaotong University