Clinical trial NCT05640336: Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periprosthetic Joint Infection
Keywords: Total knee arthroplasty
Total hip arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with a chronic PJI, defined as: presentation of symptoms \> 4 weeks in duration.
* Revision surgery or previous two-stage reimplantation.

Primary outcomes:
measure: Subjects free from failure
timeFrame: 1 year following DAIR.
Secondary outcomes:
measure: Readmission within 90 days of the surgical DAIR procedure
timeFrame: 90 days following DAIR procedure
measure: 1-year surgical reoperation rate
timeFrame: 1 year following DAIR procedure
measure: 5-year surgical reoperation rate
timeFrame: 5 years following DAIR procedure
measure: 10-year surgical revision rate
timeFrame: 10 years following DAIR procedure
measure: Hospital length of stay
timeFrame: Approximately 2 weeks following DAIR procedure
measure: Resource analysis
timeFrame: Approximately 2 weeks following DAIR procedure
measure: Clinical Outcome Scores
timeFrame: 1, 5, and 10 years following DAIR procedure
measure: Adverse events
timeFrame: 10 years following DAIR procedure
measure: Survivorship
timeFrame: 10 years following DAIR procedure
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Abdel, MD
role: PRINCIPAL_INVESTIGATOR
References: