Periprosthetic Joint Infection
Conditions
Keywords
Total knee arthroplasty, Total hip arthroplasty
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).
Interventions
PROCEDURESingle 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.
PROCEDUREPlanned 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.
Sponsors
Columbia University
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects free from failure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year surgical reoperation rate | 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 | 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 | 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 | Approximately 2 weeks following DAIR procedure | Total number of days subjects were admitted to the hospital |
| Readmission within 90 days of the surgical DAIR procedure | 90 days following DAIR procedure | Total number of subjects to required hospital readmission within 90 days of DAIR. |
| Clinical Outcome Scores | 1, 5, and 10 years following DAIR procedure | Evaluation of patient reported Harris Hip or Knee Society Scores |
| Adverse events | 10 years following DAIR procedure | Total number of subjects to experience adverse events related to either drug or the surgical procedure |
| Survivorship | 10 years following DAIR procedure | Total number of subject deaths post-surgical DAIR procedure |
| Resource analysis | Approximately 2 weeks following DAIR procedure | Hospital admission cost comparison between the two study arms |
Countries
United States
Outcome results
None listed