Total Knee ArthroplastyNCT07232771
Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies
An observational study of Total Knee Arthroplasty and Reinfection, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty, Reinfection, Aseptic Loosening
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies: a Single Centre Retrospective Observational Study
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.
Read the detailed description
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. In this study, we aimed to evaluate: (1) the postoperative reinfection rates following four surgical strategies for TKA-PJI; (2) the microbial profile of recurrent infections; (3) short- and long-term infection-free implant survival rates across the four surgical approaches; (4) re-revision rates due to aseptic loosening and long-term aseptic loosening-free implant survival rates; and (5) the reinfection rate in patients with positive cultures at the time of reimplantation. In order 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)
- Medical subject headings
- Reinfection
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-revision rate
Re-revisions with implant exchange
Measured: 5 year after surgery
Reinfection rate
Reinfection rate
Measured: 2 and 5 year after surgery
Infection-free survival rate
Infection-free survival rate
Measured: 2 and 5 year after surgery
All-cause revision rates
All-cause revision rates
Measured: 5 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Liu Zhang, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232771
- Sponsor's protocol ID
- MTCA,ECFAH of FMU[2019]296
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinfection and Re-revision Rates of Periprosthetic Knee Infection Under Four Different Surgical Strategies: a Single Centre Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07232771
- Acronym / sponsor ID
- MTCA,ECFAH of FMU[2019]296
- Conditions
- Total Knee Arthroplasty, Reinfection, Aseptic Loosening, Revision, Periprosthetic Joint Infection (PJI)
- Keywords
- Total Knee Arthroplasty, Reinfection, Aseptic Loosening, Revision, Periprosthetic joint infection (PJI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Nov 2025 (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.
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.
Detailed description
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. In this study, we aimed to evaluate: (1) the postoperative reinfection rates following four surgical strategies for TKA-PJI; (2) the microbial profile of recurrent infections; (3) short- and long-term infection-free implant survival rates across the four surgical approaches; (4) re-revision rates due to aseptic loosening and long-term aseptic loosening-free implant survival rates; and (5) the reinfection rate in patients with positive cultures at the time of reimplantation. In order to provide reference value for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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
Re-revision rate
Time frame: 5 year after surgery
Re-revisions with implant exchange
Reinfection rate
Time frame: 2 and 5 year after surgery
Reinfection rate
Infection-free survival rate
Time frame: 2 and 5 year after surgery
Infection-free survival rate
All-cause revision rates
Time frame: 5 year after surgery
All-cause revision rates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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. This study is not recruiting at the moment.
Liu Zhang study director
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Reinfection, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-revision rate (time frame: 5 year after surgery). The study lists 4 primary outcomes in all. 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 18 Nov 2025.