Knee Osteoarthritis, Rheumatoid Arthritis (RA)
Conditions
Keywords
Total Knee Arthroplasty, TKA, Cost-Effectiveness, Prosthesis Selection, Real-World Study
Brief summary
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.
Detailed description
This is a single-center, retrospective, open-label, non-randomized cohort study based on real-world clinical data from the Second Affiliated Hospital of Wenzhou Medical University. The study population will include all adult patients who underwent first-time unilateral primary total knee arthroplasty (TKA) between January 1, 2022 and December 31, 2025. Patients who underwent revision arthroplasty, simultaneous bilateral arthroplasty, concomitant arthroplasty of other joints, arthroplasty for tumor or acute trauma, or who had severely incomplete data will be excluded. Participants will be grouped according to the prosthesis brand and model documented in the operative record. Baseline variables will include age, sex, body mass index, preoperative diagnosis, ASA classification, comorbidities, and preoperative knee function score. Surgery-related variables will include prosthesis brand and model, fixation method, operative duration, intraoperative blood loss, surgeon seniority, use of a tourniquet, and drainage duration. The primary outcome will be knee function score at 1 year after surgery, assessed using the HSS score or KSS score. Secondary outcomes will include postoperative complications, length of hospital stay, functional recovery, quality of life, and patient-reported outcomes at different postoperative time points. Economic outcomes will include direct medical costs, direct non-medical costs, indirect costs, and cost-effectiveness analysis. Safety outcomes will include all postoperative adverse events. The objective of this study is to comprehensively compare the medium- and long-term clinical effectiveness, safety, and economic benefits of different prosthesis brands used in TKA, and to provide evidence to support clinical prosthesis selection and healthcare resource optimization.
Interventions
None listed
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Function Score at 1 Year After Surgery | 1 year after surgery | The KSS ranges from 0 to 100, with higher scores indicating better knee function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | Perioperative through 5 years after surgery | 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 | From surgery to hospital discharge, assessed up to 30 days | Length of hospital stay after primary unilateral total knee arthroplasty. |
| Postoperative Knee Function Score | 1 month, 3 months, 6 months, 3 years, and 5 years after surgery | 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 | 1 month, 3 months, 6 months, 3 years, and 5 years after surgery | 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). |
| Direct Medical Costs | From hospitalization through 5 years after surgery | Direct medical costs associated with primary unilateral total knee arthroplasty, including total hospitalization cost, prosthesis material cost, medication cost, examination cost, surgery and anesthesia cost, bed and nursing cost, and follow-up cost. |
| Direct Non-Medical Costs | From hospitalization through 5 years after surgery | Direct non-medical costs associated with primary unilateral total knee arthroplasty, including caregiver expenses, transportation costs, and accommodation costs for non-local medical visits. |
| Indirect Costs | From hospitalization through 5 years after surgery | Indirect costs associated with primary unilateral total knee arthroplasty, including productivity loss where available. |
| Incremental Cost-Effectiveness Ratio | At end of analysis | Cost-effectiveness evaluated by incremental cost-effectiveness ratio (ICER), including the cost required for each 1-point improvement in the Hospital for Special Surgery (HSS) score. |
| Postoperative Adverse Events | From surgery through 5 years after surgery | All postoperative adverse events recorded during the study follow-up period. |
Contacts
CONTACTTing Li, MD, PhD
CONTACTXiaoyun Pan, MD, PhD
Outcome results
None listed