Men and Women With Different Designs and Semi-individual Total Knee Replacement
NCT ID: NCT04976400
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1600 participants
INTERVENTIONAL
2022-01-01
2025-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
NCT03059927
Study Comparing Traditional and Gender-specific Total Knee Replacement Designs
NCT00937170
Kinematics of Contemporary Knee Arthroplasty
NCT02965690
Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches
NCT07348835
Anterior Knee Pain Between Unisex Knee Prosthesis VS Gender Specific Knee Prosthesis Following MIS TKA
NCT05045651
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
test group
Semi-individualized total knee arthroplasty
semi-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.
Control group
Zimmer standard prosthesis total knee replacement
Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)
Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
semi-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.
Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)
Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥50, ≤80 years old.
3. Subjects or guardians are willing and able to sign informed consent.
Exclusion Criteria
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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guizhou Orthopedics Hospital
UNKNOWN
Shenyang Orthopedic Hospital
OTHER
West China Hospital
OTHER
Xi'an Honghui Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
Jining Medical University
OTHER
Northern Jiangsu People's Hospital
OTHER
Inner Mongolia People's Hospital
OTHER
Shenzhen Pingle Orthopedics Hospital
UNKNOWN
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jiakuo Yu, Doctor
Role: STUDY_CHAIR
Peking University Third Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M2021299
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.