anterior medial osteoarthritis or spontaneous osteonecrosis of the knee joint
Conditions
Interventions
experimental group:sensor bearing assisted judgment of soft tissue tension
Control group:Using traditional method to judge soft tissue tension
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients should have indications for UKA (anterior medial osteoarthritis of knee joint) or (spontaneous osteonecrosis of the knee), and conservative treatment is ineffective. 2) 45 -75 years old; 3) BMI <= 35 Kg/m2; 4) The bones are mature, and their health is stable according to physical examination and medical history and willing to be followed up after operation. 5) The operated knee is to perform UKA for the first time. 6) Did not participate in other clinical trials in the 12 months before participating in this clinical trial; 7) Before the operation, the subjects were willing and able to sign the informed consent form (ICF) approved by the institutional review committee (IRB), the ethics committee (EC) or the ethics review committee (ERB).
Exclusion criteria
Exclusion criteria: 1) Ipsilateral hip had joint replacement has been performed in the past year, and contralateral knee arthroplasty is expected to be performed one year after operation. 2) Lateral compartment knee arthritis; lateral patellofemoral joint arthritis with dislocation; fixed flexion contracture or varus deformity greater than 10 degrees; subluxation greater than 5 mm; 3) Inflammatory arthropathy; 4) Allergic to any implant components (for example, metal or polyethylene); 5) Unable to support and / or fix the prosthesis due to diseases (such as tumor, severe osteoporosis, metabolic osteopathy, radiation osteopathy, etc.). 6) Acute or chronic, local or systemic infection (including infection history) or septicemia, active infection lesions in the knee joint or other parts of the body; 7) Pregnant women or lactating women; 8) The contralateral knee joint has been included in this study; 9) The affected knee had undergone patellar surgery, patellar resection, high tibial osteotomy and other surgical operations; 10) Tumor, cachexia, alcohol or drug addiction and / or mental illness, which the researchers thought might affect their participation in this study; 11) Major neurological or musculoskeletal diseases or diseases that may adversely affect gait or weight bearing (e.g., but not limited to muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease); 12) Unable to talk, read and understand questions freely, and could not complete the subject subjective questionnaire. 13) life expectancy of less than 2 years. 14) Can not comply with the follow-up requirements or affect the scientific integrity of the study; 15) Currently participating in another experimental drug or device study; 16) Hemoglobin < 11 g / L; 17) Albumin < 90% of the normal low limit; 18) C-reactive protein (CRP) was more than 2 times higher than the normal high limit; 19) The (ESR) of ESR is more than 2 times of the normal high limit; 20) Abnormal blood coagulation test, which can not be corrected or replaced; 21) The researchers believe that patients are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KSS knee score; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS pain score;flexion angle;FJS score;postoperative complications; | — |
Countries
China
Contacts
Public ContactWei Chai
Chinese PLA General Hospital
Outcome results
None listed