NCT07553871

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started May 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 10, 2026

Last Update Submit

April 20, 2026

Conditions

Knee OsteoarthritisRheumatoid Arthritis (RA)

Keywords

Total Knee ArthroplastyTKACost-EffectivenessProsthesis SelectionReal-World Study

Outcome Measures

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.

    1 year after surgery

Secondary Outcomes (9)

  • Postoperative Complications

    Perioperative through 5 years after surgery

  • Length of Postoperative Hospital Stay

    From surgery to hospital discharge, assessed up to 30 days

  • Postoperative Knee Function Score

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

  • Quality of Life and Patient-Reported Outcomes

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

  • Direct Medical Costs

    From hospitalization through 5 years after surgery

  • +4 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ting Li, MD, PhD

CONTACT

86+13587876896liting1021@aliyun.com

Xiaoyun Pan, MD, PhD

CONTACT

xiaoyunpan@wmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 28, 2026

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.