Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies

NCT07232771 | Completed DMC

• 1 other identifier: MTCA,ECFAH of FMU[2019]296
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center retrospective cohort study was conducted in the Department of Orthopedics, the First Affiliated Hospital of Fujian Medical University. This study reviewed 145 patients who underwent debridement, antibiotics, and implant retention (DAIR), 1-stage revision, 1.5-stage revision, and 2-stage revision surgeries for total knee arthroplasty periprosthetic joint infection (TKA-PJI) at this institution between 2012 and 2022. The differences in postoperative reinfection rate, microbial composition of reinfection, short-term and long-term aseptic prosthesis survival rate, prosthesis loosening and revision rate due to any cause, and long-term loosening-free survival rate among the four revision surgical approaches for TKA-PJI were evaluated, so as to provide reference value for clinical decision-making.

Conditions

Total Knee Arthroplasty; Reinfection; Aseptic Loosening; Revision; Periprosthetic Joint Infection (PJI)

Keywords

Total Knee Arthroplasty; Reinfection; Aseptic Loosening; Revision; Periprosthetic joint infection (PJI)

Outcome Measures

Primary Outcomes (4)

• Re-revision rate

  Re-revisions with implant exchange

  5 year after surgery

• Reinfection rate

  Reinfection rate

  2 and 5 year after surgery

• Infection-free survival rate

  Infection-free survival rate

  2 and 5 year after surgery

• All-cause revision rates

  All-cause revision rates

  5 year after surgery

Study Arms (4)

DAIR group

DAIR revision involves washout, thorough debridement, antibiotics, and all components of implant retention, but polyethylene exchange

1-stage revision group

One-stage revision involves open debridement of the infected knee, followed by immediate revision by removal and or reimplantation of all components

1.5-stage revision group

The 1.5-stage revision involves the use of a functional, articulating antibiotic-loaded knee spacer intended for long-term retention-either indefinitely or until loosening necessitates definitive TKA revision. We standardize the terminology for this procedure as "1.5-stage revision", as it represents an intermediate strategy between one-stage and two-stage revision for the treatment of PJI following TKA

2-stage revision group

Two-stage revision, with removal of implants, placement of an antibiotic spacer, and parenteral antibiotic treatment followed by TKA reimplantation has been proposed as the "gold standard" for chronic PJI treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the inclusion criteria, 145 patients who underwent DAIR, phase 1 revision, phase 1.5 revision, and phase 2 revision surgery for TKA-PJI at the institution between 2012 and 2022 were selected. All patients have completed at least 2 years of follow-up. Follow up includes prosthesis loosening, infection recurrence rate, infection recurrence rate, infection new incidence rate, bacterial positive culture rate, infection free survival rate, and revision rate for any reason. Sampling Method

You may qualify if:

• Patients who met the diagnostic criteria for TKA-PJI;
• Patients who underwent one of the following surgical interventions: DAIR, one-stage revision, 1.5-stage revision, or two-stage revision;
• Patients with complete medical records available;
• Patients who provided informed consent to participate in the study.

You may not qualify if:

• Incomplete medical records;
• Poor follow-up compliance, including inability to complete scheduled follow-up visits or refusal to participate in follow-up;
• Follow-up duration less than 2 years.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Reinfection

Condition Hierarchy (Ancestors)

Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liu Zhang

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: November 18, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

CN (1)