Comparative Study on the Medium- and Long-term Benefits of Prosthesis Selection in Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

3,500 Participants
are grouped into 2 trial groups
Group A: Mainstream Prosthesis Cohort
Group B: Emerging Prosthesis Cohort

Trial outcomes

Primary outcomes

1

Knee Function Score at 1 Year After Surgery

The KSS ranges from 0 to 100, with higher scores indicating better knee function.

Time frame
1 year after surgery

Secondary outcomes

1

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.

Time frame
Perioperative through 5 years after surgery
2

Length of Postoperative Hospital Stay

Length of hospital stay after primary unilateral total knee arthroplasty.

Time frame
From surgery to hospital discharge, assessed up to 30 days
3

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).

Time frame
1 month, 3 months, 6 months, 3 years, and 5 years after surgery
4

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).

Time frame
1 month, 3 months, 6 months, 3 years, and 5 years after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: