Clinical trial NCT07003035: A Multi-Center Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
Official title: A Multi-Center Prospective Cohort Study on the Clinical Advantages of Personalized Total Knee Arthroplasty System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Shougang Hospital
name: Beijing Chao Yang Hospital
First posted: 2025-06-04
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit adult patients aged 50-80 years who are undergoing total knee arthroplasty for end-stage knee osteoarthritis or related conditions. Participants will be selected from multiple hospital centers to ensure a diverse patient population.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Society Score (KSS)
timeFrame: At baseline, 6 months, and 12 months post-surgery
Secondary outcomes:
measure: Pain Severity - Visual Analog Scale (VAS)
timeFrame: At baseline, 6 months, and 12 months post-surgery.
measure: Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: At baseline, 6 months, and 12 months post-surgery
measure: Functional Improvement - SF-36 Health Survey
timeFrame: At baseline, 6 months, and 12 months post-surgery.
measure: Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At baseline, 6 months, and 12 months post-surgery
measure: Functional Improvement - Gait Analysis
timeFrame: At baseline, 6 months, and 12 months post-surgery
measure: Prosthesis Positioning and Alignment
timeFrame: At baseline and 12 months post-surgery.
measure: Surgical Complication Rate
timeFrame: At 12 months post-surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
Study officials:
References: