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

N/ANot Yet RecruitingNCT06990594

Beijing Tsinghua Chang Gung Hospital120 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Osteoarthritis

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Knee Society Score (KSS)

The KSS is a standardized assessment tool used to evaluate knee function and pain following total knee arthroplasty. It includes an objective knee score and a functional score, measuring alignment, stability, and range of motion.

Time frame: At baseline, 6 months, and 12 months post-surgery

Secondary Outcomes

Pain Severity

Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess pain levels pre- and post-surgery.

Time frame: At baseline, 6 months, and 12 months post-surgery

Functional Improvement

Functional improvement will be measured using SF-36 Health Survey, Knee Injury and Osteoarthritis Outcome Score (KOOS), and gait analysis.

Time frame: At baseline, 6 months, and 12 months post-surgery.

Prosthesis Positioning and Alignment

Radiographic evaluation will assess implant positioning and limb alignment.

Time frame: At baseline and 12 months post-surgery.

Surgical Complication Rate

The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.

Time frame: At 12 months post-surgery.

Data from ClinicalTrials.gov

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