Bone diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 21 to 75 years; 2. Able to perform surgical operations and cooperate with follow-up follow-up, with good compliance; 3. Unilateral knee replacement is required; 4. Have well-functioning ligaments; 5. Voluntarily participate in this trial and sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Subjects who have undergone replacement of the major joints (hip and knee) of the ipsilateral lower extremity; 2. Participated in clinical investigators of other investigational drugs or devices within the past 3 months. 3. Fixed flexion contracture or varus deformity greater than 15 degree; 4. There is ankylosing deformity of the hip or ankle; 5. Known or suspected to be allergic to polyethylene, titanium, cobalt, chromium or iron-containing materials; 6. The subject is immunosuppressed, suffering from autoimmune disease or immunosuppressive disorder; 7. The subject cannot support and/or fix the prosthesis due to disease (such as tumor, severe osteoporosis, or metabolic bone disease, etc.); 8. Unable to understand the requirements of participating in the research, or unable to complete the research follow-up plan; 9. Other investigators think that it is not suitable for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deviation angle of lower limb alignment;Knee Society Score;Three dimensional gait analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery success rate;Intraoperative blood loss;Operation time;Postoperative hospital stay; | — |
Countries
China
Contacts
The First Affiliated Hospital of Army Military Medical University