A Prospective Cohort Clinical Trial Study of Prosthesis and Surgery Guide System for Personalized Total Knee Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Peking University Third Hospital
- Enrollment
- 80
- Primary Endpoint
- Mechanical axis of the lower limb and prosthesis position
- Last Updated
- 4 years ago
Overview
Brief Summary
The subject is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides.
Detailed Description
The subject continues the research of Professor Jia-kuo Yu's research group on the personalized design, processing and manufacturing of personalized total knee arthroplasty (TKA) prostheses and the verification of animal and human cadavers. It is planned to carry out the clinical trails of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis; At the same time, in order to achieve personalized precision bone resection, the clinical trial verification is carried out on the personalized cutting guides. In the clinical validation study, the research team will summarize the role of personalized TKA prostheses and personalized TKA cutting guides in the precise and minimally invasive treatment of knee osteoarthritis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Degenerative osteoarthritis, traumatic arthritis or avascular necrosis, inflammatory joint disease and other end-stage knee joint diseases, as well as the 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.
- •The subject or guardian is willing and able to sign an informed consent form.
Exclusion Criteria
- •History of previous knee surgery.
- •Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability;
- •Severe flexion contracture deformity (flexion contracture\> 25°);
- •Perform total knee joint revision and replacement surgery;
- •Rheumatoid arthritis;
- •Body Mass Index (BMI) \>
- •Patients with neuromuscular insufficiency (for example, paralysis, myolysis or muscle weakness) can lead to postoperative knee instability or abnormal gait;
- •Pregnant or lactating women;
- •Suffer from the underlying medical condition (including but not limited to metabolism, hematology, kidney, liver, lung, nerve, endocrine, heart, infection or gastrointestinal tract) that the researcher believes that the patient is at an unacceptable risk; Serious progressive or uncontrolled diseases that are not suitable for trials or put them at high risk, including any medical or psychiatric conditions that the investigator believes will prevent subjects from following the protocol or completing the study according to the protocol.
- •Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C, or a corresponding medical history.
Outcomes
Primary Outcomes
Mechanical axis of the lower limb and prosthesis position
Time Frame: 12 months postoperatively
Axis through the center of the hip joint, the center of the knee joint, and the center, (-3,3) is normal.
Secondary Outcomes
- KSS score(12 months postoperatively)
- Operation time(during surgery)
- VAS score(12 months postoperatively)
- WOMAC score(12 months postoperatively)
- SF-36 score(12 months postoperatively)
- Osteotomy during TKA(during surgery)