Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?

• Status: Enrolling by invitation
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of Study: In order to improve upon the variable results seen in irrigation and debridement for periprosthetic infection, we ask if the use of intraosseous regional administration of antibiotics at the time of irrigation and debridement will improve the modest success of standard irrigation and debridement. We will use the existing literature on standard irrigation and debridement procedures to compare with the results of the irrigation and debridement with the use of intraosseous antibiotics.

Impact Question:

How will this study benefit the patient? Currently when an I&D fails, the patient needs to undergo two more major procedures: 1) implant removal and 2) reimplantation of the prosthesis. Any improvement in the results of a standard irrigation and debridement procedure may decrease the number of patients having to go through further extensive procedures to cure their infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborator: American Association of Hip and Knee Surgeons
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Vancomycin

Criteria

Inclusion Criteria (to be completed at time of consent) I. Acute perioperative periprosthetic infection in the first 90 days following primary surgery OR, II. Acute hematogenous infection with symptoms less than four weeks OR, III. Any patient with a chronic periprosthetic knee infection, or a prosthetic knee that is considered unresectable due to the presence of extremely difficult to extract implants such as cones/sleeves/or long cemented or cementless stems and indicated for an irrigation debridement procedure.

IV. Patients indicated for an irrigation debridement procedure of a knee periprosthetic knee joint infection as defined by the inclusion criteria noted above with a gram positive organism susceptible to vancomycin, defined as:

1. A sinus communicating with the prosthesis, OR

2. Two positive cultures obtained from the prosthesis, OR

3. 3 of 5 criteria:

i. Elevated ESR (>30mm/hr) and CRP (>10mg/L) ii. Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip iii. Elevated synovial neutrophil percentage (>80%) iv. One positive culture v. Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400) We understand that on occasion, irrigation & debridement is performed emergently, therefore enrollment may continue without all laboratory/cultures completed. All inclusion criteria in this situation will be confirmed postoperatively.

V. Any patient >18 years old

Exclusion Criteria I. Surgical wound that cannot be closed. II. Patients with an acute PJI greater than 90 days following primary surgery (using standard implants).

III. Hematogenous infection with symptoms greater than four weeks IV. Know hypersensitivity to Vancomycin V. Major Renal disease defined as creatinine > 2.0 (See previous comments, No Red Man syndrome in 2 subsequent studies on intraosseous vancomycin in revision TKA and High BMI patients respectively (9). Additionally, systemic levels were 8 times lower with intraosseous antibiotics than IV Vancomycin.) VI. Unable to use a tourniquet due to vascular disease VII. Pregnant women VIII. Allergy to antibiotic

Screen Failure (following initial procedure):

IX. Culture negative infections whereby the infecting organism was not identified OR X. Vancomycin-resistant organisms