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One-Stage Versus Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection: A Prospective Randomized Trial
Thomas K Fehring1, Jesse E Otero1, Keith A Fehring1
1OrthoCarolina Hip & Knee Center, Charlotte, North Carolina.
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.
Insights
The one-stage treatment for periprosthetic joint infection (PJI) showed a 97% success rate, proving non-inferior to the 91% success rate of the two-stage approach in a randomized trial. This study included complex cases, offering a viable alternative for PJI management.
Area of Science:
- Orthopedic Surgery
- Infectious Diseases
- Clinical Trials
Background:
- Periprosthetic joint infection (PJI) is commonly treated with a two-stage surgical approach.
- Previous one-stage PJI treatment studies were limited by small sample sizes and exclusion of complex cases.
- The high morbidity and cost of two-stage PJI treatment necessitate investigation into alternative methods.
Purpose of the Study:
- To prospectively compare the efficacy of one-stage versus two-stage treatment for chronic periprosthetic joint infection (PJI).
- To include patients with challenging conditions such as draining sinuses, comorbidities, and antibiotic-resistant organisms in the comparison.
- To evaluate clinical success rates at two-year follow-up for both treatment modalities.
Main Methods:
- A prospective, multicenter, randomized trial involving 323 patients with chronic PJI following primary total hip or knee arthroplasty.
- Patients were randomized into either one-stage or two-stage treatment groups, with strict inclusion/exclusion criteria.
- Clinical success was defined as absence of failure, reinfection, reoperation for PJI, or PJI-related death, assessed at two-year follow-up.
Main Results:
- The two-year success rate for the one-stage treatment group was 97% (131/135), compared to 91% (112/123) for the two-stage group (p = 0.04).
- Regression analysis indicated that one-stage treatment had three times the odds of overall success compared to two-stage treatment, even after adjusting for host factors and organism resistance.
- Sixteen patients in the one-stage group and 9 in the two-stage group died before the two-year follow-up.
Conclusions:
- One-stage treatment is statistically non-inferior to two-stage treatment for chronic PJI in primary total hip or knee arthroplasty when specific protocols are followed.
- The findings support the one-stage approach as an effective alternative, particularly in complex patient populations.
- Results should be applied cautiously and not extrapolated to different patient cohorts or clinical scenarios.
