JBJS - 2026-07-15 - Journal Article; Randomized Controlled Trial; Multicenter Study; Comparative Study
One-Stage Versus Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection: A Prospective Randomized Trial.
Fehring TK, Otero JE, Fehring KA, Curtin BM, Springer BD, Della Valle CJ, Parvizi J, Hietpas K, Ready A, Odum SM, the PJI Study Group
Topics
Key Takeaway
One-stage exchange arthroplasty achieved 97% 2-year success versus 91% for two-stage exchange (p=0.04, OR 3.22) in chronic PJI following primary THA or TKA.
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Summary
This prospective multicenter RCT compared one-stage versus two-stage exchange arthroplasty for chronic PJI (MSIS criteria) following primary THA or TKA, including patients with draining sinuses, comorbidities, and resistant organisms. Using McPherson host staging and standardized double-instrument and antibiotic protocols, 323 patients were randomized. One-stage treatment achieved 97% success versus 91% for two-stage (p=0.04), with an unadjusted OR of 3.22 (95% CI 1.0–10.38) favoring one-stage, which persisted after adjusting for host grade, resistant organism, and draining sinus status.
Key Limitation
The 20% attrition rate—with disproportionately higher mortality in the one-stage group (16 vs. 9 deaths)—was excluded from the success analysis rather than counted as failure, potentially inflating the one-stage success rate.
Original Abstract
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.