Clinical trial NCT04976400: Men and Women With Different Designs and Semi-individual Total Knee Replacement
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Total knee replacement
gender
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Guizhou Orthopedics Hospital
name: Shenyang Orthopedic Hospital
name: West China Hospital
name: Xi'an Honghui Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Jining Medical University
name: Northern Jiangsu People's Hospital
name: Inner Mongolia People's Hospital
name: Shenzhen Pingle Orthopedics Hospital
First posted: 2021-07-26
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: lower limb alignment
timeFrame: Before operation
measure: lower limb alignment
timeFrame: 5 days after operation
measure: lower limb alignment
timeFrame: 6 months after operation
measure: lower limb alignment
timeFrame: 12 months after operation
measure: Knee prosthesis position
timeFrame: 5 days after operation
measure: Knee prosthesis position
timeFrame: 6 months after operation
measure: Knee prosthesis position
timeFrame: 12 months after operation
measure: Gait analysis
timeFrame: 5 days after operation
measure: Gait analysis
timeFrame: 6 months after operation
measure: Gait analysis
timeFrame: 12 months after operation
Secondary outcomes:
measure: Operation time
timeFrame: during surgery
measure: The amount of bleeding
timeFrame: during surgery
measure: VAS score
timeFrame: Before operation
measure: VAS score
timeFrame: 5 days after operation
measure: VAS score
timeFrame: 6 months after operation
measure: VAS score
timeFrame: 12 months after operation
measure: KSS score
timeFrame: Before operation
measure: KSS score
timeFrame: 5 days after operation
measure: KSS score
timeFrame: 6 months after operation
measure: KSS score
timeFrame: 12 months after operation
measure: WOMAC score
timeFrame: Before operation
measure: WOMAC score
timeFrame: 5 days after operation
measure: WOMAC score
timeFrame: 6 months after operation
measure: WOMAC score
timeFrame: 12 months after operation
measure: SF-36 score
timeFrame: Before operation
measure: SF-36 score
timeFrame: 5 days after operation
measure: SF-36 score
timeFrame: 6 months after operation
measure: SF-36 score
timeFrame: 12 months after operation
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Jiakuo Yu, Doctor
role: STUDY_CHAIR
References: