osteoarthritis
Conditions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age range of 18 to 80 years old (including 18 and 80 years old), gender is not limited; (2) Subjects who require initial and unilateral knee unicompartmental replacement surgery; (3) The subjects or their guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with a body mass index (BMI) = 35.0kg/m2; (2) Severe medial and lateral deformity of the knee joint (inversion or eversion greater than 15 º) that cannot be passively corrected; (3) Knee joint flexion deformity greater than 15 º or flexion range of motion less than 90 º; (4) Individuals with a history of knee joint and periarticular surgery within the past three months; (5) Joint lesions involving multiple compartments, including inflammatory joint diseases such as rheumatoid arthritis and hemophilia arthritis, contralateral Patients with interstitial osteoarthritis, etc; (6) There are diseases that affect implant fixation or joint stability (such as those with postoperative ligament dysfunction or knee extension device injury) Subject); (7) There is a metallic implant in the lower limb on the surgical side; (8) Patients with contraindications for unicompartmental knee arthroplasty, such as: a) lower limb paralysis or presence of neurodegenerative joint disease (Charcot joint) The person; b) Neuromuscular dysfunction in the lower limbs (such as sequelae of polio, muscle weakness, etc.) can lead to postoperative knee joint instability Individuals with abnormal gait or difficulty in recovery; c) Individuals with abnormal blood glucose, liver and kidney, and coagulation function (fasting blood glucose>8.0mmol/L, liver and kidney dysfunction) Functional abnormalities (ALT, AST>2 times the upper limit of normal, blood Scr>2 times the upper limit of normal), coagulation dysfunction (blood Small board1.5 times the upper limit of normal value), etc; d) Individuals with active infections around the knee joint or throughout the body; (9) History of allergies to implant materials or surgical instruments; (10) Subjects with consciousness disorders or inability to cooperate with treatment; (11) Pregnant or lactating women, or those who plan to conceive during the trial period; (12) Study participants who participated in other clinical trials three months prior to treatment; (13) The researchers believe that participants who are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Internal and external flip angle of femoral prosthesis;Knee society score;Western Ontario and McMaster Universities osteoarthritis index, WOMAC;Knee joint range of motion;Overall functional evaluation; | — |
Countries
China
Contacts
Public ContactZongke Zhou
West China Hospital of Sichuan University
Outcome results
None listed