The patient requires total knee arthroplasty due to severe knee pain, joint deformity, and limited joint mobility.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.18< = age< = 85 years old, gender is not limited; 2. Unilateral primary total knee arthroplasty to be performed; 3. The subject or his/her guardian is informed of this study and agrees to all the terms of this trial, signs the informed consent form approved by the ethics committee, and agrees to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Joint lesions in the lower limbs on the side to be operated with obvious bone defects or significant limitation of joint movement; 2. Uncontrolled acute and chronic infections at the proposed surgical site or throughout the body; 3. Body mass index (BMI) >35kg/m^2; 4. Suffering from severe osteoporosis; 5. Suffering from mental illness, lower limb neuromuscular disease and other diseases that affect the normal function and rehabilitation after surgery; 6. Patients with severe cardiopulmonary insufficiency, liver and kidney insufficiency, etc., who cannot tolerate surgery; 7. Those who are known to be allergic to implanted prosthetic materials; 8. There is a bone tumor at the proposed surgical site; 9. The subject is a pregnant or lactating female; 10. Participated in or is participating in clinical trials of other drugs, biological agents or devices within 1 month before the proposed enrollment; 11. Other circumstances judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The deformation under a 100N valgus stress; | — |
Secondary
| Measure | Time frame |
|---|---|
| HKA angle;Knee joint ROM, KSS score, SF-36 score, WOMAC score, pain score;The deformation under a 100N varus stress; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Xi'an Jiaotong University