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

Arthroplasty, Replacement, Knee Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04976400
• Other study ID #: M2021299
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Jiakuo Yu, Doctor
• Phone: 13331031448
• Email: yujiakuo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Peking University Third Hospital	First Affiliated Hospital of Chongqing Medical University, Guizhou Orthopedics Hospital, Inner Mongolia People's Hospital, Jining Medical University, Northern Jiangsu Province People's Hospital, Shenyang Orthopedic Hospital, Shenzhen Pingle Orthopedics Hospital, The Affiliated Hospital Of Guizhou Medical University, West China Hospital, Xi'an Honghui Hospital

Outcome

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