Men and Women With Different Designs and Semi-individual Total Knee Replacement

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: semi-individualized total knee replacement treatment with a gender-specific design
* Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)


Participation Criteria
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Eligibility Criteria
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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)> 35. 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. Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C, or a corresponding medical history. 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. Active systemic infections (except colds) or any other infections that will recur regularly during the previous two weeks. A history of chronic or recurrent infectious diseases, or evidence of tuberculosis infection that was determined to be positive at the time of screening. 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. 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). 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). 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. During the six months before the baseline, there was a history of alcohol or drug abuse or evidence of ongoing abuse. The patient is mentally incapable or unable to understand the requirements for participating in the research.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>Semi-individualized total knee arthroplasty | Procedure: semi-individualized total knee replacement treatment with a gender-specific design<br>* Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.<br>|
| Active Comparator: Control group<br>Zimmer standard prosthesis total knee replacement | Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)<br>* Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower limb alignment | 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. | Before operation | 
| lower limb alignment | 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. | 5 days after operation | 
| lower limb alignment | 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. | 6 months after operation | 
| lower limb alignment | 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. | 12 months after operation | 
| Knee prosthesis position | Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse. | 5 days after operation | 
| Knee prosthesis position | Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse. | 6 months after operation | 
| Knee prosthesis position | Coronal angle of femoral prosthesis and Coronal angle of tibial prosthesis，180° is normal. The more deviated from 180°, the worse. | 12 months after operation | 
| Gait analysis | Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement. | 5 days after operation | 
| Gait analysis | Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement. | 6 months after operation | 
| Gait analysis | Through the gait analysis platform and data acquisition system, Evaluate the patient's gait to achieve functional assessment of postoperative human movement. | 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | from cutting the skin to completing the suture of the incision | during surgery | 
| The amount of bleeding | from cutting the skin to completing the suture of the incision | during surgery | 
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | Before operation | 
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 5 days after operation | 
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 6 months after operation | 
| VAS score | Visual Analogue Scale/Score, the scale is 0-10 and 10 is worse. | 12 months after operation | 
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | Before operation | 
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 5 days after operation | 
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 6 months after operation | 
| KSS score | knee society score, the scale is 0-200 and 0 is worse. | 12 months after operation | 
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | Before operation | 
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 5 days after operation | 
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 6 months after operation | 
| WOMAC score | The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, the scale is 0-100 and 100 is worse. | 12 months after operation | 
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | Before operation | 
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 5 days after operation | 
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 6 months after operation | 
| SF-36 score | short form 36 questionnaire, scale is 0-100 and 0 is worse. | 12 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee replacement, gender