Periprosthetic Joint InfectionNCT05640336
Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
A study testing Single Debridement, Antibiotics and Implant Retention and Planned Double Debridement, Antibiotics and Implant Retention in people with Periprosthetic Joint Infection, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection
- What is being tested?
- Single Debridement, Antibiotics and Implant Retention and Planned Double Debridement, Antibiotics and Implant Retention
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2023to Mar 2032
- Phase
- Interventional
- 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
Who may be able to join
- Patients who speak English and are willing to sign the consent form
- Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms < 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as:
- A sinus communicating with the prosthesis OR
- Two positive cultures obtained from the prosthesis OR
- 4 of 5 criteria: Elevated ESR (> 30mm/hr) and CRP (> 10mg/L); Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on; leukocyte esterase strip; Elevated synovial neutrophil percentage (> 80%); One positive culture; Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high; Power field in 5 high power fields x 400).
- OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR
Who cannot join
- Patients with a chronic PJI, defined as: presentation of symptoms > 4 weeks in duration.
- Revision surgery or previous two-stage reimplantation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial
The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).
- Conditions
- Periprosthetic Joint Infection
- Being tested
- Single Debridement, Antibiotics and Implant Retention, Planned Double Debridement, Antibiotics and Implant Retention
- Keywords
- Total knee arthroplasty, Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Debridement, Antibiotics and Implant RetentionProcedure or surgery
Surgical debridement and wash out of infected joint. The polyethylene (plastic) insert, which acts as the articulating surface (modular component) of the prosthesis, will be removed and the exposed surfaces scrubbed, sterilized, and soaked. A new modular component will be placed with additional irrigation and antiseptic soak. Tissue cultures will be sent to the lab for further evaluation and antibiotic guidance. After the operation subjects will continue six weeks of IV antibiotics followed by oral antibiotic suppression for the life of the implant or at least two years after operation.
Planned Double Debridement, Antibiotics and Implant RetentionProcedure or surgery
Surgical debridement and wash out of infected joint with an additional irrigation and debridement scheduled for approximately 5 days after the initial DAIR. During the first washout, antibiotic cement beads will be placed in the joint and these will remain in the interim until they are removed during the second washout. During the second DAIR, the antibiotic beads are removed, and the modular components are once again removed and replaced with new components. Exposed surfaces are again irrigated and debrided following a standardized protocol. A six-week course of IV antibiotics will follow the DAIR with additional oral antibiotics for the life of the component (standard of care) or at least a minimum of two years.
| Study group | Role | What they receive |
|---|---|---|
| Single DAIR Surgery Arm | Active comparator | Subjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care. Receives: Procedure: Single Debridement, Antibiotics and Implant Retention |
| Double DAIR Surgery Arm | Active comparator | Subjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care. Receives: Procedure: Planned Double Debridement, Antibiotics and Implant Retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects free from failure
Total number of subjects considered failure free at one year from surgical DAIR procedure. Failure is defined as reoperation for infection within one year from surgical procedure.
Measured: 1 year following DAIR.
Secondary outcomes (9)
Readmission within 90 days of the surgical DAIR procedure
Total number of subjects to required hospital readmission within 90 days of DAIR.
Measured: 90 days following DAIR procedure
1-year surgical reoperation rate
Total number of subjects to require reoperation or revision with or without infection within one year from the surgical DAIR procedure.
Measured: 1 year following DAIR procedure
5-year surgical reoperation rate
Total number of subjects to require reoperation or revision with or without infection within five years from the surgical DAIR procedure.
Measured: 5 years following DAIR procedure
10-year surgical revision rate
Total number of subjects to require reoperation or revision with or without infection within ten years from the surgical DAIR procedure.
Measured: 10 years following DAIR procedure
Hospital length of stay
Total number of days subjects were admitted to the hospital
Measured: Approximately 2 weeks following DAIR procedure
Resource analysis
Hospital admission cost comparison between the two study arms
Measured: Approximately 2 weeks following DAIR procedure
Clinical Outcome Scores
Evaluation of patient reported Harris Hip or Knee Society Scores
Measured: 1, 5, and 10 years following DAIR procedure
Adverse events
Total number of subjects to experience adverse events related to either drug or the surgical procedure
Measured: 10 years following DAIR procedure
Survivorship
Total number of subject deaths post-surgical DAIR procedure
Measured: 10 years following DAIR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start3 Mar 2023
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640336
- Sponsor's protocol ID
- 22-006739
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05640336
- Acronym / sponsor ID
- 22-006739
- Conditions
- Periprosthetic Joint Infection
- Keywords
- Total knee arthroplasty, Total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 7 Dec 2022 (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.
The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single DAIR Surgery Arm | Active comparator | Procedure: Single Debridement, Antibiotics and Implant RetentionSubjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care. |
| Double DAIR Surgery Arm | Active comparator | Procedure: Planned Double Debridement, Antibiotics and Implant RetentionSubjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who speak English and are willing to sign the consent form
- Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms < 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as:
- OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR
Key exclusion criteria (2 listed)
- Patients with a chronic PJI, defined as: presentation of symptoms > 4 weeks in duration.
- Revision surgery or previous two-stage reimplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Debridement, Antibiotics and Implant RetentionSurgical debridement and wash out of infected joint. The polyethylene (plastic) insert, which acts as the articulating surface (modular component) of the prosthesis, will be removed and the exposed surfaces scrubbed, sterilized, and soaked. A new modular component will be placed with additional irrigation and antiseptic soak. Tissue cultures will be sent to the lab for further evaluation and antibiotic guidance. After the operation subjects will continue six weeks of IV antibiotics followed by oral antibiotic suppression for the life of the implant or at least two years after operation. | Procedure or surgery | Single DAIR Surgery Arm |
| Planned Double Debridement, Antibiotics and Implant RetentionSurgical debridement and wash out of infected joint with an additional irrigation and debridement scheduled for approximately 5 days after the initial DAIR. During the first washout, antibiotic cement beads will be placed in the joint and these will remain in the interim until they are removed during the second washout. During the second DAIR, the antibiotic beads are removed, and the modular components are once again removed and replaced with new components. Exposed surfaces are again irrigated and debrided following a standardized protocol. A six-week course of IV antibiotics will follow the DAIR with additional oral antibiotics for the life of the component (standard of care) or at least a minimum of two years. | Procedure or surgery | Double DAIR Surgery Arm |
Primary outcome
Subjects free from failure
Time frame: 1 year following DAIR.
Total number of subjects considered failure free at one year from surgical DAIR procedure. Failure is defined as reoperation for infection within one year from surgical procedure.
9 secondary outcomes
Readmission within 90 days of the surgical DAIR procedure
Time frame: 90 days following DAIR procedure
1-year surgical reoperation rate
Time frame: 1 year following DAIR procedure
5-year surgical reoperation rate
Time frame: 5 years following DAIR procedure
10-year surgical revision rate
Time frame: 10 years following DAIR procedure
Hospital length of stay
Time frame: Approximately 2 weeks following DAIR procedure
Resource analysis
Time frame: Approximately 2 weeks following DAIR procedure
Clinical Outcome Scores
Time frame: 1, 5, and 10 years following DAIR procedure
Adverse events
Time frame: 10 years following DAIR procedure
Survivorship
Time frame: 10 years following DAIR procedure
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 18 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Matthew Abdel, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Debridement, Antibiotics and Implant Retention and Planned Double Debridement, Antibiotics and Implant Retention in people with Periprosthetic Joint Infection, run by Mayo Clinic at 2 sites in United States.
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 6 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
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?
Subjects free from failure (time frame: 1 year following DAIR.). 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 Dec 2025.