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

NCT04976400 | Unknown

• 1 other identifier: M2021299
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Total knee replacement; gender

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (18)

• Operation time

  during surgery

• The amount of bleeding

  during surgery

• VAS score

  Before operation

• VAS score

  5 days after operation

• VAS score

  6 months after operation

Study Arms (2)

test group

EXPERIMENTAL

Semi-individualized total knee arthroplasty

Procedure: semi-individualized total knee replacement treatment with a gender-specific design

Control group

ACTIVE COMPARATOR

Zimmer standard prosthesis total knee replacement

Procedure: Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)

Interventions

semi-individualized total knee replacement treatment with a gender-specific design PROCEDURE

Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.

test group

Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA) PROCEDURE

Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Guizhou Orthopedics Hospital: collaborator
• Shenyang Orthopedic Hospital: collaborator
• West China Hospital: collaborator
• Xi'an Honghui Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Jining Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Inner Mongolia People's Hospital: collaborator
• Shenzhen Pingle Orthopedics Hospital: collaborator

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Jiakuo Yu, Doctor

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Jiakuo Yu, Doctor

CONTACT

13331031448; yujiakuo@126.com

Fuzhen Yuan, Doctor

CONTACT

18511440808; yuanfuzhen2016@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 26, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 26, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share