Research on Clinical Solutions of Artificial Joints for Men and Women With Different Designs and Semi-individual Total Knee Replacement：A Prospective Cohort Clinical Trial Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthroplasty, Replacement, Knee
- Sponsor
- Peking University Third Hospital
- Enrollment
- 1600
- Primary Endpoint
- Knee prosthesis position
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including:
- Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method.
- To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy.
- Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.
Detailed Description
Patients meeting the inclusion and exclusion criteria were divided into the experimental group and the control group according to the patient's wishes. Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design. The control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Various end-stage knee joint diseases such as degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease, as well as correction of deformities, reconstruction after failure of some knee joint prostheses, and other techniques that cannot be handled In the case of fractures, total knee prosthesis replacement is required.
- •Age ≥50, ≤80 years old.
- •Subjects or guardians are willing and able to sign informed consent.
Exclusion Criteria
- •History of previous knee surgery.
- •Severe knee deformity (valgus greater than 15° or valgus greater than 20°) or knee instability;
- •Severe flexion contracture deformity (flexion contracture\> 25°);
- •Undertake total knee joint revision and replacement surgery;
- •Rheumatoid arthritis;
- •Body Mass Index (BMI)\>
- •Patients with neuromuscular insufficiency (such as paralysis, myolysis, or muscle weakness) can lead to postoperative knee instability or abnormal gait;
- •Pregnant or breastfeeding women;
- •Suffer from the underlying medical condition that the researcher believes that the patient is at an unacceptable risk (including but not limited to metabolism, hematology, kidney, liver, lung, nerve, endocrine, heart, infection, or gastrointestinal tract);
- •the current patient is not suitable Tests or severely progressive or uncontrolled diseases that put them at high risk, including any medical or psychiatric conditions that the investigator believes will prevent the subject from following the protocol or completing the study according to the protocol.
Outcomes
Primary Outcomes
Knee prosthesis position
Time Frame: 12 months after operation
Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse.
lower limb alignment
Time Frame: 12 months after operation
Full-length frontal radiographs of both lower extremities; both lower extremities and one-leg weight-bearing positive radiographs; （-3 3）is normal, The more out of this range, the worse.
Gait analysis
Time Frame: 12 months after operation
Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement.
Secondary Outcomes
- VAS score(12 months after operation)
- WOMAC score(12 months after operation)
- KSS score(12 months after operation)
- Operation time(during surgery)
- The amount of bleeding(during surgery)
- SF-36 score(12 months after operation)