Introduction

Surgical management of PJI remains challenging with patients failing treatment despite the best efforts. An important question is whether these later failures reflect reinfection or the persistence of infection. Proponents of reinfection believe hosts are vulnerable to developing infection and new organisms emerge. The alternative hypothesis is that later failure is a result of an organism that was present in the joint but was not picked up by initial culture or was not a pathogen initially but became so under antibiotic pressure. This multicenter study explores the above dilemma. Utilizing next-generation sequencing (NGS), we hypothesize that failures after two stage exchange arthroplasty can be caused by an organism that was present at the time of initial surgery but not isolated by culture.

Introduction

Total hip arthroplasty (THA) is a commonly performed procedure to relieve arthritis or traumatic injury. However, implant failure can occur from implant loosening or crevice corrosion as a result of inadequate seating of the femoral head onto the stem during implantation. There is no consensus—either by manufacturers or by the surgical community—on what head/stem assembly procedure should be used to maximize modular junction stability. Furthermore, the role of “off-axis” loads—loads not aligned with the stem taper axis—during assembly may significantly affect modular junction stability, but has not been sufficiently evaluated.

Introduction

Improper seating during head/stem assembly can lead to unintended micromotion between the femoral head and stem taper—resulting in fretting corrosion and implant failure. There is no consensus—either by manufacturers or by the surgical community—on what head/stem taper assembly method maximizes modular junction stability in total hip arthroplasty (THA). A 2018 clinical survey found that orthopedic surgeons prefer applying one strike or three, subsequent strikes when assembling head/stem taper. However, it has been suggested that additional strikes may lead to decreased interference. Additionally, the taper surface finish—micro-grooves—has been shown to affect taper interference and may be influenced by assembly method.

Introduction

Modular junctions in total hip replacement (THR) have been a primary source of fretting and corrosion which can lead to implant failure. Fretting is a result of unintended micromotion between the femoral head and stem tapers and is suspected to result after improper taper seating during assembly. Two design factors known to influence in-vitro taper assembly mechanics are relative taper alignment—mismatch angle—and the surface finish—micro-grooves. However, these factors have not been systematically evaluated together.

The purpose of this randomized controlled trial is to evaluate the efficacy of using dilute betadine versus sterile saline lavage in aseptic revision total knee (TKA) and hip (THA) arthroplasty to prevent acute postoperative deep periprosthetic joint infection (PJI).

Of the 450 patients that were randomized, 5 did not have 90-day follow-up, 9 did not receive the correct treatment, and 4 were excluded for intraoperative findings consistent with PJI. 221 Patients (144 knees and 77 hips) received saline lavage only and 211 (136 knees and 75 hips) received a three-minute dilute betadine lavage (0.35%) prior to wound closure. Patients were observed for the incidence of acute postoperative deep PJI within 90 days of surgery. Statistical analysis was performed using t-tests or Fisher's exact test where appropriate. Power analysis determined that 285 patients per group are needed to detect a reduction in the rate of PJI from 5% to 1% (alpha=0.05, beta=0.20).

There were seven PJIs in the saline group and one in the betadine lavage group (3.2% vs. 0.5%, p=0.068). There were no significant differences in any baseline demographics between groups suggesting appropriate randomization.

Although we believe the observed difference between treatments is clinically relevant, it was not statistically significant with the sample size enrolled thus far and enrollment is ongoing. Nonetheless, we believe that these data suggests that dilute betadine lavage is a simple method to reduce the rate of acute postoperative PJI in patients undergoing aseptic revision procedures.