Knee OsteoarthritisNCT07553871
Comparative Study on the Medium- and Long-term Benefits of Prosthesis Selection in Total Knee Arthroplasty
An observational study of Knee Osteoarthritis and Rheumatoid Arthritis (RA), run by Second Affiliated Hospital of Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Rheumatoid Arthritis (RA)
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaoyun Pan, MD, PhD contact
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Rheumatoid Arthritis (RA)
- Keywords
- Total Knee Arthroplasty, TKA, Cost-Effectiveness, Prosthesis Selection, Real-World Study
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mainstream Prosthesis Cohort | Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using established mainstream prosthesis brands during the study period. | |
| Emerging Prosthesis Cohort | Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using emerging prosthesis brands during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Function Score at 1 Year After Surgery
The KSS ranges from 0 to 100, with higher scores indicating better knee function.
Measured: 1 year after surgery
Secondary outcomes (9)
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.
Measured: Perioperative through 5 years after surgery
Length of Postoperative Hospital Stay
Length of hospital stay after primary unilateral total knee arthroplasty.
Measured: From surgery to hospital discharge, assessed up to 30 days
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).
Measured: 1 month, 3 months, 6 months, 3 years, and 5 years after surgery
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).
Measured: 1 month, 3 months, 6 months, 3 years, and 5 years after surgery
Direct Medical Costs
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.
Measured: From hospitalization through 5 years after surgery
Direct Non-Medical Costs
Direct non-medical costs associated with primary unilateral total knee arthroplasty, including caregiver expenses, transportation costs, and accommodation costs for non-local medical visits.
Measured: From hospitalization through 5 years after surgery
Indirect Costs
Indirect costs associated with primary unilateral total knee arthroplasty, including productivity loss where available.
Measured: From hospitalization through 5 years after surgery
Incremental Cost-Effectiveness Ratio
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.
Measured: At end of analysis
Postoperative Adverse Events
All postoperative adverse events recorded during the study follow-up period.
Measured: From surgery through 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start31 May 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553871
- Sponsor's protocol ID
- SAHoWMU-CR2026-08-208
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. The study uses retrospective hospital medical record data, and data sharing is limited by institutional regulations, ethics requirements, and the need to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Medium- and Long-term Benefits of Prosthesis Selection in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07553871
- Acronym / sponsor ID
- SAHoWMU-CR2026-08-208
- Conditions
- Knee Osteoarthritis, Rheumatoid Arthritis (RA)
- Keywords
- Total Knee Arthroplasty, TKA, Cost-Effectiveness, Prosthesis Selection, Real-World Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mainstream Prosthesis Cohort | – | –Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using established mainstream prosthesis brands during the study period. |
| Emerging Prosthesis Cohort | – | –Patients who underwent first-time unilateral primary total knee arthroplasty (TKA) using emerging prosthesis brands during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee Function Score at 1 Year After Surgery
Time frame: 1 year after surgery
The KSS ranges from 0 to 100, with higher scores indicating better knee function.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. The study uses retrospective hospital medical record data, and data sharing is limited by institutional regulations, ethics requirements, and the need to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyun Pan, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Rheumatoid Arthritis (RA), run by Second Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Li, MD, PhD (86+13587876896, liting1021@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Function Score at 1 Year After Surgery (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.