About this trial
This retrospective real-world study aims to compare the medium- and long-term clinical outcomes, safety, and economic benefits of different knee prosthesis brands used in primary unilateral total knee arthroplasty (TKA) at our hospital. The study will include adult patients who underwent first-time unilateral TKA between January 1, 2022 and December 31, 2025. Outcomes such as postoperative knee function, complications, length of hospital stay, quality of life, and medical costs will be evaluated. The results are expected to provide evidence to support prosthesis selection and optimize healthcare resource allocation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years.
Diagnosis of end-stage knee osteoarthritis, rheumatoid arthritis, or other conditions meeting the indication for TKA.
First-time unilateral knee arthroplasty.
Complete medical records, including perioperative records, prosthesis model records, detailed cost information, and regular postoperative follow-up records.
Disqualifiers
Revision knee arthroplasty, simultaneous bilateral arthroplasty, or concomitant arthroplasty of other joints.
Arthroplasty performed for non-degenerative conditions such as tumour or acute trauma.
Perioperative death or loss to follow-up.
Severely incomplete clinical data that preclude valid analysis.
Trial population
The study population will include adult patients who underwent first-time unilateral primary total knee arthroplasty at the Second Affiliated Hospital of Wenzhou Medical University between January 1, 2022 and December 31, 2025. Eligible patients must have complete perioperative records, prosthesis model information, cost data, and postoperative follow-up records. Patients undergoing revision arthroplasty, simultaneous bilateral arthroplasty, concomitant arthroplasty of other joints, or arthroplasty for tumor or acute trauma will be excluded.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Knee Function Score at 1 Year After Surgery
The KSS ranges from 0 to 100, with higher scores indicating better knee function.
Secondary outcomes
Postoperative Complications
Complications occurring after primary unilateral total knee arthroplasty, including but not limited to infection, deep vein thrombosis, periprosthetic fracture, and prosthesis loosening. Complications will be assessed during the perioperative period and at 1 month, 3 months, 6 months, 1 year, 3 years, and 5 years after surgery.
Length of Postoperative Hospital Stay
Length of hospital stay after primary unilateral total knee arthroplasty.
Postoperative Knee Function Score
Postoperative knee function assessed using the Hospital for Special Surgery Knee Score (HSS; range 0 to 100, with higher scores indicating better knee function) or the Knee Society Score (KSS; range 0 to 100, with higher scores indicating better outcome).
Quality of Life and Patient-Reported Outcomes
Quality of life and patient-reported outcomes assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; total score range 0 to 96, with higher scores indicating worse pain, stiffness, and functional limitation) and/or the EuroQol 5-Dimension questionnaire (EQ-5D; higher index scores indicating better health status, depending on the value set applied).
Locations
Sponsors and contacts
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