A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis

Beijing Tsinghua Chang Gung Hospital

Status: Not yet enrolling

Conditions: Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT06990594

25034-0-02

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (TKA) in osteoarthritis treatment. The study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional TKA in a multi-center, bidirectional cohort study.

Full description

This study aims to assess the performance of personalized, semi-personalized, and conventional total knee arthroplasty (TKA) procedures across different patient groups.

This is a prospective cohort and controlled study involving 120 patients, including 40 in the experimental group receiving personalized TKA, 40 receiving semi-personalized TKA, and 40 in the control group receiving conventional TKA. 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: 120 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.
10. Active or recent severe infections or malignancy.
11. History of drug or alcohol abuse in the past six months.

Trial design

120 participants in 1 patient group

Cohort 1

Description:

A total of 120 participants will be enrolled, with 40 receiving total knee arthroplasty (TKA) using a personalized prosthesis, 40 receiving semi-personalized TKA, and 40 receiving conventional TKA. Participants will be followed for one year post-surgery to assess clinical outcomes.