A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System

YujiakuoTHU

Status: Not yet enrolling

Conditions: Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT07003035

23705-4-02

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical benefits of personalized total knee arthroplasty (TKA) in comparison with conventional TKA. The study aims to assess surgical outcomes, functional recovery, complication rates, and cost-effectiveness in a multi-center, prospective cohort study.

Full description

This study builds on long-term research on the design, manufacturing, and validation of personalized total knee arthroplasty (TKA) prostheses . The clinical study aims to assess the performance of the femoral, tibial, and meniscal components within a personalized TKA system.

This is a prospective cohort and controlled study involving 80 patients, including 40 in the experimental group and 40 in the control group. Participants will be 50-80 years old, diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, inflammatory arthritis, or deformities requiring total knee arthroplasty. They will be followed for one year post-surgery to assess clinical outcomes.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 50-80 years.
2. Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
3. Willing and able to provide informed consent.

Exclusion criteria

1. History of prior knee surgery or knee replacement.
2. Severe knee deformity (valgus >20° or varus >15°) or instability.
3. Severe contracture (>25° flexion contracture).
4. Undergoing total knee revision surgery.
5. Rheumatoid arthritis diagnosis.
6. BMI >35.
7. Neuromuscular disorders affecting knee stability or gait.
8. Pregnancy or lactation.
9. Presence of significant comorbidities posing unacceptable risk, including but not limited to metabolic, renal, hepatic, pulmonary, cardiac, hematologic, neurological, endocrine, infectious, or gastrointestinal conditions.
10. Active or recent severe infections or malignancy.
11. History of drug or alcohol abuse in the past six months.

Trial design

80 participants in 1 patient group

Cohort 1

Description:

A total of 80 participants will be enrolled, with 40 receiving personalized total knee arthroplasty and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.