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.
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.
Study Type
OBSERVATIONAL
Enrollment
80
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Knee Society Score (KSS)
The Knee Society Score is a standardized assessment tool to evaluate pain, range of motion, and functional ability following total knee arthroplasty. It includes two sub-scores: a clinical knee score and a functional score. Each sub-score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: At baseline, 6 months, and 12 months post-surgery
Pain Severity - Visual Analog Scale (VAS)
Pain severity will be measured using the VAS, a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Time frame: At baseline, 6 months, and 12 months post-surgery.
Pain Severity - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Pain will also be assessed using the WOMAC Pain Subscale, part of the validated WOMAC Index for knee osteoarthritis. Each item is scored from 0 to 4, and the subscale total ranges from 0 (no pain) to 20 (maximum pain). Higher scores indicate worse pain.
Time frame: At baseline, 6 months, and 12 months post-surgery
Functional Improvement - SF-36 Health Survey
Physical function will be assessed using the 36-Item Short Form Health Survey (SF-36). The Physical Functioning domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: At baseline, 6 months, and 12 months post-surgery.
Functional Improvement - Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a validated tool assessing knee function across five domains. Each domain score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.
Time frame: At baseline, 6 months, and 12 months post-surgery
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Functional Improvement - Gait Analysis
Gait performance will be evaluated using temporospatial parameters such as gait speed (m/s), step length (cm), and cadence (steps/min), measured using standardized motion capture or pressure-sensitive walkways.
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.