Clinical trial NCT06990594: A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis
Official title: A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis
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: 2025-05-25
Enrollment: 120
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: The study population consists of 120 patients aged 50-80 years diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis, who require total knee arthroplasty (TKA). Participants will be recruited from multiple centers, including Beijing Tsinghua Chang Gung Hospital, Peking University Shougang Hospital, and Beijing Chaoyang Hospital. The study will compare personalized, semi-personalized, and conventional TKA procedures in terms of surgical outcomes, functional recovery, complication rates, and cost-effectiveness.

Brief summary: 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.

Detailed 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.

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.
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
timeFrame: At baseline, 6 months, and 12 months post-surgery
measure: Functional Improvement
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: