osteoarthritis
Conditions
Sponsors
The First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 to 80 years old (including 18 and 80 years old), gender is not limited; (2) Patients requiring primary a and unilateral total knee replacement; (3) The subject or his/her guardian can understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Subjects with a body mass index (BMI) =35.0kg/m2; (2) severe inversion deformity of the knee joint (inversion or valgus greater than 15º), and cannot be passively corrected; (3) knee flexion deformity greater than 30º or flexion motion less than 60º; (4) the knee is installed in the damaged image and sound of the implant test object) solid; Definite or joint stability disease (such as: loss of intraoperative ligament structure, extension (5) in the last three months with a history of knee and periarticular surgery; (6) There is a gold implant in the lower extremity of the operative side; (7) Patients with contraindications for total knee replacement, such as: a) patients with lower limb paralysis or neuropathic joint disease (Charcot joint); b) Lower extremity neuromuscular dysfunction (such as poliomyelitis sequelae, muscle weakness, etc.) will lead to postoperative knee instability, abnormal gait or difficult recovery; c) Patients with abnormal blood glucose, liver and kidney function and coagulation function (fasting blood glucose >8.0mmol/L, abnormal liver and kidney function (ALT and AST > 2 times the upper limit of normal value, Scr> 2 times the upper limit of normal value), coagulation dysfunction (platelet count 1.5 times the upper limit of normal value), etc. d) Active infected persons around the knee or throughout the body; (8) History of allergy to implant materials or surgical instruments; (9) Subjects with impaired consciousness or unable to cooperate with treatment; (10) Pregnant or lactating women, or those who planned pregnancy during the trial period; (11) Participants who participated in other clinical trials 3 months prior to the study treatment; (12) Subjects deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Implant accuracy;Knee society score;Western Ontario and McMaster Universities osteoarthritis index, WOMAC;Knee joint range of motion;Overall functional evaluation; | — |
Countries
China
Contacts
Public ContactLi Cao
The First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed