Knee arthritis
Conditions
Interventions
sensor bearing group:sensor
conventional group:tenson balance evaluated by surgeon
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) aged 50 to 75 years; 2) BMI is less than or equal to 35; 3) the bone of the patient has matured, according to the physical examination and medical history, the patient is in stable health condition, can carry out surgical operation and participate in subsequent trial items, and can follow up; 4) the patient had good functional ligaments; 5) patients should have indications for single condylar knee replacement (for example, knee joint function loss caused by joint pain or traumatic osteoarthritis, which can not be relieved by non-surgical method; Radiographs of the affected knee joint showed that the medial tibial joint space was obviously narrow and the lateral space was normal, and the lateral film showed that the wear was located in front of the medial platform, which was consistent with the manifestation of anterior medial osteoarthritis); 6) the affected limb on the affected side underwent single condylar placement for the first time; 7) did not participate in other clinical trials 3 months before participating in this clinical trial; 8) the estimated postoperative survival time was more than two years; 9) the patients volunteered to participate in this clinical trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) subjects who had undergone replacement of the main joints of the ipsilateral lower extremities (hip and knee joint) in the past 12 months; 2) arthritis of lateral compartment knee; 3) arthritis of the lateral articular surface of patellofemoral joint with dislocation; 4) fixed flexion contracture or varus deformity more than 10 degrees; 5) subluxation greater than 5 mm; 6) inflammatory arthropathy; 7) there is extensive ligament relaxation; 8) the subjects were allergic to the implant, allergic physique or allergic to multiple drugs; 9) it is known that the subjects have insufficient bone mass due to diseases (such as tumor, severe osteoporosis, or metabolic bone disease) and are unable to support and / or fix the prosthesis; 10) Acute or chronic, local or systemic infection (including history of infection) or septicemia, active infection focus in knee joint or other parts of the body; 11) the subjects suffered from diseases that could endanger the stability of the implant or surgical rehabilitation (such as deformed osteitis or neuroarthropathy, structural injury of collateral ligament, vascular insufficiency, muscle atrophy, uncontrolled diabetes mellitus and moderate to severe renal insufficiency). Can not follow up or affect the scientific integrity of the test; 12) patients with mental illness or patients are mentally incompetent or unable to understand the requirements for participation in the study; 13) the subjects were in a state of immunosuppression and suffered from autoimmune diseases or immunosuppressive disorders; 14) pregnant and lactating women; 15) long-term alcoholism, drug abuse and other patients; 16) those who are in critical condition and are difficult to evaluate the effectiveness and safety of the equipment; 17) patients who need bilateral simultaneous replacement or contralateral replacement for 1 year; 18) other researchers do not consider it appropriate for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HSS score;Adverse events and complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxford Knee Score;SF-12 score;WOMAC score;Radiological evaluation;Survivorship of prosthesis; | — |
Countries
China
Contacts
Public ContactWei Chai
Chinese PLA General Hospital
Outcome results
None listed