Principal Investigator: Jeremy Gililland
Keywords: Next-Gen sequencing , Infection , Total Joint Arthroplasty , Periprosthetic Joint Infection Department: Orthopedic Surgery Operations
IRB Number: 00106237 Co Investigator: Christopher Peters
Specialty: Orthopaedic Surgery
Sub Specialties: Adult Reconstruction
Recruitment Status: Enrolling by invitation

Contact Information

Brenna Blackburn

Brief Summary

The purpose of this clinical trial is to investigate the outcome of one-stage and two-stage exchange arthroplasty for the management of patients with chronic PJI. The hypothesis of this non-inferiority study is that one-stage exchange arthroplasty, if performed in the appropriate patient population, carries a similar success rate for the treatment of chronic PJI as two-stage exchange arthroplasty and avoids many of the problems associated with two-stage exchange arthroplasty.

Inclusion Criteria

Participants will be considered to be included in this trial if they satisfy all of the following criteria:

1.   Patients >18 years old

2.   Patients who speak English and are willing to sign the consent form

3.   Patients with chronic infection of a total knee or total hip arthroplasty, 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)

Exclusion Criteria

Participants will be excluded if they satisfy any of the following criteria:

1.   Culture negative infections whereby the infecting organism has not been identified.

2.   Patients with systemic sepsis who require emergent surgery

3.   Patients with extensive soft tissue involvement that would preclude the closure of the wound after reimplantation, if the patient were to undergo the one-stage exchange

4.   Patients with acute PJI or acute hematogenous PJI, defined as

            a.  Presentation of symptoms <4 weeks from index procedure

            b.  Presentation of symptoms <4 week duration

5.   Fungal infections

6.   Resistant organisms not sensitive to available IV antibiotics, oral antibiotics, or heat stable antibiotic additives to bone cement with documented elution characteristics.

7.   Revision surgery or previous two-stage reimplant

8.   HIV positive patients or patients on chemotherapy