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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Procedure: semi-individualized total knee replacement treatment with a gender-specific design; Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiakuo Yu, Doctor; Phone Number: 13331031448; Email: yujiakuo@126.com
• Study Contact Backup: Name: Fuzhen Yuan, Doctor; Phone Number: 18511440808; Email: yuanfuzhen2016@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; Semi-individualized total knee arthroplasty	Procedure: 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.
Active Comparator: Control group; Zimmer standard prosthesis total knee replacement	Procedure: 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: West China Hospital; The Affiliated Hospital Of Guizhou Medical University; Northern Jiangsu Province People's Hospital; First Affiliated Hospital of Chongqing Medical University; Inner Mongolia People's Hospital; Jining Medical University; Xi'an Honghui Hospital; Guizhou Orthopedics Hospital; Shenyang Orthopedic Hospital; Shenzhen Pingle Orthopedics Hospital
• Investigators: Study Chair: Jiakuo Yu, Doctor, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Total knee replacement; gender
• Other Study ID Numbers: M2021299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No