Background: A 2-stage approach is most commonly used to treat periprosthetic joint infection (PJI). Some successful studies of the 1-stage approach were underpowered, lacked a 2-stage comparative group, and excluded patients with draining sinuses, comorbidities, and/or antibiotic-resistant organisms. Given the morbidity and expense associated with 2-stage treatment, we conducted a prospective, multicenter, randomized trial to compare the results of 1- and 2-stage PJI treatment, specifically including patients with draining sinuses, comorbidities, and resistant organisms. Methods: Patients presenting for surgical treatment of a chronic PJI with a known organism following primary total hip or knee arthroplasty were included (with infection defined by Musculoskeletal Infection Society [MSIS] criteria). Patients with prior revision, culture-negative infection, or fungal infection, or who were immunosuppressed or had soft-tissue involvement precluding wound closure, were excluded. Patients were classified according to the McPherson host staging system. Clinical success was defined as (1) no clinical failure or reinfection with the same or new organism; (2) no reoperation for PJI; and (3) no PJI-related death. A double-instrument setup was used for all patients, as were similar irrigation and antibiotic protocols. A total of 323 patients (166 one-stage; 157 two-stage) were randomized. Groups were similar with respect to demographics and host classification. After excluding patients who died or were lost to follow-up, 258 of the 323 patients had 2-year follow-up (135 one-stage and 123 two-stage). The rate of patient loss to follow-up was similar between the treatment groups. Results: Sixteen patients in the 1-stage group and 9 patients in the 2-stage group died prior to 2-year follow-up. Overall, the 2-year success rate of 1-stage treatment was 97% (131 of 135), while the success of 2-stage treatment was 91% (112 of 123) (p = 0.04). Compared with the 2-stage group, the 1-stage group had 3-times the odds of overall success in a regression analysis (unadjusted odds ratio = 3.22 [95% confidence interval = 1.0 to 10.38]). After adjusting for specific variables (McPherson host grade, resistant organism, and draining sinuses), 1-stage treatment also had 3-times the odds of success. Conclusions: The results of this prospective randomized trial indicated that 1-stage treatment (97% success) was statistically noninferior to 2-stage treatment (91% success) when treating chronic PJI following primary total hip or knee arthroplasty, provided the protocols described here are explicitly followed. Extrapolation to other patient cohorts and clinical situations should be avoided. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
Background: Two-stage exchange arthroplasty after a previous, failed 2-stage exchange procedure is fraught with difficulties, and there are no clear guidelines for treatment or prognosis given the heterogeneous group of patients in whom this procedure has been performed. The Musculoskeletal Infection Society (MSIS) staging system was developed in an attempt to stratify patients according to infection type, host status, and local soft-tissue status. The purpose of this study was to report the results of 2-stage exchange arthroplasty following a previous, failed 2-stage exchange protocol for periprosthetic knee infection as well as to identify risk factors for failure. Methods: We retrospectively identified 45 patients who had undergone 2 or more 2-stage exchange arthroplasties for periprosthetic knee infection from 2000 to 2013. Patients were stratified according to the MSIS system, and risk factors for failure were analyzed. The minimum follow-up was 2 years (mean, 6 years; range, 24 to 132 months). Results: At the time of follow-up, twenty-two (49%) of the patients had undergone another revision due to infection and 28 (62%) had undergone another revision for any reason. The infection recurred in 6 (75%) of 8 substantially immunocompromised hosts (MSIS type C) and in 3 (30%) of 10 uncompromised hosts (type A) following the second 2-stage exchange arthroplasty (p = 0.06). The infection recurred in 4 (80%) of 5 patients with compromise of the extremity (MSIS type 3) and 3 (33%) of 9 patients with an uncompromised extremity (type 1) (p = 0.27). Both extremely compromised hosts with an extremely compromised extremity (type C3) had recurrence of the infection whereas 3 (30%) of the 10 uncompromised patients with no or less compromise of the extremity (type A1 or A2) did. Five patients in the failure group underwent a third 2-stage exchange arthroplasty following reinfection, and 3 of them were infection-free at the time of the latest follow-up. Conclusions: Uncompromised hosts (MSIS type A) with an acceptable wound (MSIS type 1 or 2) had a 70% rate of success (7 of 10) after a repeat 2-stage exchange arthroplasty, whereas type-B2 hosts had a 50% success rate (10 of 20). The repeat 2-stage exchange procedure failed in both type-C3 hosts; thus, alternative salvage procedures should be considered for such patients. Level of Evidence: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.