About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 50-80 years.
Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.
Willing and able to provide informed consent.
Disqualifiers
History of prior knee surgery or knee replacement.
Severe knee deformity (valgus >20° or varus >15°) or instability.
Severe contracture (>25° flexion contracture).
Undergoing total knee revision surgery.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial 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.
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.
Functional Improvement
Functional improvement will be measured using SF-36 Health Survey, Knee Injury and Osteoarthritis Outcome Score (KOOS), and gait analysis.
Prosthesis Positioning and Alignment
Radiographic evaluation will assess implant positioning and limb alignment.
Surgical Complication Rate
The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.
Sponsors and contacts
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Beijing Tsinghua Chang Gung Hospital
Lead sponsor
Peking University Shougang Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
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