# Development of an Antimicrobial Pedicle Screw System:  Studies Designed to Mitigate the Risk of Bacterial Resistance

> **NIH NIH R43** · ORTHOBOND CORPORATION · 2022 · $146,428

## Abstract

PROJECT SUMMARY/ABSTRACT
Chronic pain at the implant site, “failed back surgery syndrome (FBSS),” is a common cause of spine fusion
failure. Over the past five years, though, multiple studies have defined a clear link between FBSS and low
levels of bacterial contamination on implant surfaces. In particular, these studies showed bacterial
contamination in 40% of cases of hardware retrieved from FBSS patients who have otherwise no clinical
signs of surgical site infection. In response to this clinical need, Orthobond has developed an antimicrobial
pedicle screw implant system utilizing a high density of covalently bound quaternary ammonium
compounds (QACs). This pedicle screw system has already demonstrated broad-spectrum antimicrobial
efficacy and good biocompatibility; however, in order to commercialize the product, it is necessary to
demonstrate that the antimicrobial implants will not promote the emergence of antibiotic-resistant
bacteria.
QACs are well-known for nearly a century in consumer products such as mouthwashes, shampoos and
surface disinfectant sprays; they suffer few reports of bacterial resistance. However, when resistance to
QACs does occur, it is through expression of one or more types of efflux pumps that work to remove QACs
before they disrupt intracellular targets. We believe that surface-tethered QACs should not be subject to
decreased efficacy by efflux pumps; these surface-bound molecules are expected to not enter the
bacterium, but rather to act on its cell wall through positive-charge promoted mechanisms. The global
aim of this proposed research also includes to implement rapid assays to determine the propensity for our
QAC-treated pedicle screw implants to allow emergence of bacterial resistance to them and to other
contact-based antimicrobials. This Phase 1 proposal consists of two specific aims, in brief:
• Aim 1 is to test whether repeated exposure of Orthobond antimicrobial pedicle screw surfaces to
 gram positive or gram negative bacteria results in decreased susceptibility of these bacteria to the
 implants or cross-resistance to commonly used antibiotics.
• Aim 2 is to test if surface-bonding the QAC to the pedicle screw system obviates the resistance
 mechanism to dissolved QACs - expression of the QacA efflux pump gene.
The design and implementation of these tests will allow for evaluation of the propensity of the Orthobond
antimicrobial pedicle screw system to promote bacterial resistance. These studies will potentially provide
critical data needed to market the antimicrobial pedicle screw system to physicians and their patients.

## Key facts

- **NIH application ID:** 10482147
- **Project number:** 1R43AI170418-01
- **Recipient organization:** ORTHOBOND CORPORATION
- **Principal Investigator:** Jordan Katz
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $146,428
- **Award type:** 1
- **Project period:** 2022-04-15 → 2022-08-01

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482147

## Citation

> US National Institutes of Health, RePORTER application 10482147, Development of an Antimicrobial Pedicle Screw System:  Studies Designed to Mitigate the Risk of Bacterial Resistance (1R43AI170418-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10482147. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*