Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
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|ClinicalTrials.gov Identifier: NCT05640336|
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2022
Last Update Posted : March 6, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Periprosthetic Joint Infection||Procedure: Single Debridement, Antibiotics and Implant Retention Procedure: Planned Double Debridement, Antibiotics and Implant Retention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 3, 2023|
|Estimated Primary Completion Date :||March 2032|
|Estimated Study Completion Date :||March 2032|
Active Comparator: Single DAIR Surgery Arm
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.
Procedure: Single Debridement, Antibiotics and Implant Retention
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.
Active Comparator: Double DAIR Surgery Arm
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.
Procedure: Planned Double Debridement, Antibiotics and Implant Retention
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.
- 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.
- Readmission within 90 days of the surgical DAIR procedure [ Time Frame: 90 days following DAIR procedure ]Total number of subjects to required hospital readmission within 90 days of DAIR.
- 1-year surgical reoperation rate [ Time Frame: 1 year following DAIR procedure ]Total number of subjects to require reoperation or revision with or without infection within one year from the surgical DAIR procedure.
- 5-year surgical reoperation rate [ Time Frame: 5 years following DAIR procedure ]Total number of subjects to require reoperation or revision with or without infection within five years from the surgical DAIR procedure.
- 10-year surgical revision rate [ Time Frame: 10 years following DAIR procedure ]Total number of subjects to require reoperation or revision with or without infection within ten years from the surgical DAIR procedure.
- Hospital length of stay [ Time Frame: Approximately 2 weeks following DAIR procedure ]Total number of days subjects were admitted to the hospital
- Resource analysis [ Time Frame: Approximately 2 weeks following DAIR procedure ]Hospital admission cost comparison between the two study arms
- Clinical Outcome Scores [ Time Frame: 1, 5, and 10 years following DAIR procedure ]Evaluation of patient reported Harris Hip or Knee Society Scores
- Adverse events [ Time Frame: 10 years following DAIR procedure ]Total number of subjects to experience adverse events related to either drug or the surgical procedure
- Survivorship [ Time Frame: 10 years following DAIR procedure ]Total number of subject deaths post-surgical DAIR procedure
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Patients with a chronic PJI, defined as: presentation of symptoms > 4 weeks in duration.
- Revision surgery or previous two-stage reimplantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05640336
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew Abdel, MD||Mayo Clinic|
|Responsible Party:||Matthew P. Abdel, M.D., Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||December 7, 2022 Key Record Dates|
|Last Update Posted:||March 6, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Total knee arthroplasty
Total hip arthroplasty