Comparative Study on the Medium- and Long-term Benefits of Prosthesis Selection in Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Knee Function Score at 1 Year After Surgery [Time frame: 1 year after surgery]
Secondary outcome measures (9)
- Postoperative Complications [Time frame: Perioperative through 5 years after surgery]
- Length of Postoperative Hospital Stay [Time frame: From surgery to hospital discharge, assessed up to 30 days]
- Postoperative Knee Function Score [Time frame: 1 month, 3 months, 6 months, 3 years, and 5 years after surgery]
- Quality of Life and Patient-Reported Outcomes [Time frame: 1 month, 3 months, 6 months, 3 years, and 5 years after surgery]
- Direct Medical Costs [Time frame: From hospitalization through 5 years after surgery]
- Direct Non-Medical Costs [Time frame: From hospitalization through 5 years after surgery]
- Indirect Costs [Time frame: From hospitalization through 5 years after surgery]
- Incremental Cost-Effectiveness Ratio [Time frame: At end of analysis]
- Postoperative Adverse Events [Time frame: From surgery through 5 years after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07553871 · SAHoWMU-CR2026-08-208