Arthroplasty, Replacement, Knee
Conditions
Keywords
Total knee replacement, gender
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: 1. 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. 2. 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. 3. 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).
Interventions
PROCEDUREsemi-individualized total knee replacement treatment with a gender-specific design
Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.
PROCEDUREZimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)
Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Sponsors
Guizhou Orthopedics Hospital
Shenyang Orthopedic Hospital
West China Hospital
Xi'an Honghui Hospital
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Guizhou Medical University
Jining Medical University
Northern Jiangsu People's Hospital
Inner Mongolia People's Hospital
Shenzhen Pingle Orthopedics Hospital
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Age ≥50, ≤80 years old. 3. Subjects or guardians are willing and able to sign informed consent.
Exclusion criteria
1. History of previous knee surgery. 2. Severe knee deformity (valgus greater than 15° or valgus greater than 20°) or knee instability; 3. Severe flexion contracture deformity (flexion contracture\> 25°); 4. Undertake total knee joint revision and replacement surgery; 5. Rheumatoid arthritis; 6. Body Mass Index (BMI)\> 35. 7. Patients with neuromuscular insufficiency (such as paralysis, myolysis, or muscle weakness) can lead to postoperative knee instability or abnormal gait; 8. Pregnant or breastfeeding women; 9. 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); 10. 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. 11. Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C, or a corresponding medical history. 12. Suffering from a progressive infection or malignant disease, can provide chest X-ray, computed tomography (CT scan) or MRI evidence within 12 weeks before screening, and it is verified by a qualified physician. 13. Active systemic infections (except colds) or any other infections that will recur regularly during the previous two weeks. 14. A history of chronic or recurrent infectious diseases, or evidence of tuberculosis infection that was determined to be positive at the time of screening. 15. Subjects who have obtained positive or uncertain results can participate in the study if they have undergone a comprehensive tuberculosis examination (according to local practice/guidelines) within 12 weeks before baseline and finally confirmed that there is no evidence of active tuberculosis. If the presence of latent tuberculosis is confirmed, treatment must be initiated and maintained in accordance with local or national guidelines before the baseline. 16. History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years (except for Bowen's disease, basal cell carcinoma, or actinic keratosis that has been treated and has no evidence of recurrence in the past 12 weeks ; Except for excised cervical carcinoma in situ or non-invasive malignant colon polyps). 17. Suffer from medical problems at the same time, including but not limited to the following: Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥95mmHg), congestive heart failure (New York Heart Association status classification III or IV). 18. Subjects with a serum creatinine level greater than 2.0 mg/dl (176.8 μmol/L). During screening, total white blood cell (WBC) count \<2500/μL, or platelet \<100000/μL or neutrophil \<1500/μL or hemoglobin \<8.5 g/dL. 19. During the six months before the baseline, there was a history of alcohol or drug abuse or evidence of ongoing abuse. 20. The patient is mentally incapable or unable to understand the requirements for participating in the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lower limb alignment | Before 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. |
| Knee prosthesis position | 5 days after operation | Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse. |
| Gait analysis | 5 days 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
| Measure | Time frame | Description |
|---|---|---|
| KSS score | Before operation | knee society score, the scale is 0-200 and 0 is worse. |
| Operation time | during surgery | from cutting the skin to completing the suture of the incision |
| SF-36 score | Before operation | short form 36 questionnaire, scale is 0-100 and 0 is worse. |
| WOMAC score | Before operation | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. |
| The amount of bleeding | during surgery | from cutting the skin to completing the suture of the incision |
| VAS score | Before operation | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. |
Contacts
Primary ContactJiakuo Yu, Doctor
Backup ContactFuzhen Yuan, Doctor
Outcome results
None listed