Stéphane Litrico1, Geoffrey Recanati2, Antoine Gennari1, Cédric Maillot2, Mo Saffarini3, Jean-Charles Le Huec4. 1. Department of Neurosurgery, Nice University Hospital, 06202, Nice, France. 2. Department of Spine Surgery, CHU Pellegrin Tripode, Bordeaux University Hospital, 33076, Bordeaux, France. 3. Centre for Health Management, Imperial College London, London, UK. 4. Department of Spine Surgery, CHU Pellegrin Tripode, Bordeaux University Hospital, 33076, Bordeaux, France. j-c.lehuec@u-bordeaux2.fr.
Abstract
PURPOSE: Single-use surgical instruments were recently introduced to improve OR efficiency and reduce infection risks. This study aimed to investigate clinical results 1 year after instrumented lumbar fusion, with the aid of single-use surgical instruments, with particular attention to surgical site infection and Oswestry Disability Index (ODI). METHOD: This prospective bi-centric study included 21 men and 28 women, aged 61.6 ± 12.8 years, that underwent short instrumented lumbar fusion for degenerative disc disease, canal stenosis, or degenerative spondylolisthesis. All patients underwent posterior or transforaminal lumbar interbody fusion, using the SteriSpine™ PS Pedicle Screw System, available in multiple traceable sterile kits. RESULTS: Instrumented fusion was performed at one level in 31, two levels in 11, three levels in 5, and four levels in 2 patients. The mean follow-up was 16.4 ± 2.1 months, during which the ODI improved by 20 or more points in 28 patients (57 %), improved by less than 20 points in 17 patients (35 %), and remained unchanged or worsened in 4 patients (8 %). Only one infection (2 %) was observed in a 60-year-old man with previous spine surgery and two additional risk factors (diabetes mellitus and BMI 38). Compared to an older series, using reusable instrumentation, performed by the same team for the same indications, the clinical outcomes were similar but the infection rate was 6 %. DISCUSSION: Single-use instrumentation could reduce the incidence of surgical site infections following lumbar fusion to acceptable levels as in hip and knee arthroplasties. The preservation of screws and rods in sterile packs until ready for insertion reduces their exposure to air-borne bacteria in the OR and eliminates their contamination through repetitive hospital sterilization. The short operation time and minimal blood loss achieved could also contribute to the reduction in infection risks. LEVEL OF EVIDENCE: Level II, prospective randomized bi-centric study.
RCT Entities:
PURPOSE: Single-use surgical instruments were recently introduced to improve OR efficiency and reduce infection risks. This study aimed to investigate clinical results 1 year after instrumented lumbar fusion, with the aid of single-use surgical instruments, with particular attention to surgical site infection and Oswestry Disability Index (ODI). METHOD: This prospective bi-centric study included 21 men and 28 women, aged 61.6 ± 12.8 years, that underwent short instrumented lumbar fusion for degenerative disc disease, canal stenosis, or degenerative spondylolisthesis. All patients underwent posterior or transforaminal lumbar interbody fusion, using the SteriSpine™ PS Pedicle Screw System, available in multiple traceable sterile kits. RESULTS: Instrumented fusion was performed at one level in 31, two levels in 11, three levels in 5, and four levels in 2 patients. The mean follow-up was 16.4 ± 2.1 months, during which the ODI improved by 20 or more points in 28 patients (57 %), improved by less than 20 points in 17 patients (35 %), and remained unchanged or worsened in 4 patients (8 %). Only one infection (2 %) was observed in a 60-year-old man with previous spine surgery and two additional risk factors (diabetes mellitus and BMI 38). Compared to an older series, using reusable instrumentation, performed by the same team for the same indications, the clinical outcomes were similar but the infection rate was 6 %. DISCUSSION: Single-use instrumentation could reduce the incidence of surgical site infections following lumbar fusion to acceptable levels as in hip and knee arthroplasties. The preservation of screws and rods in sterile packs until ready for insertion reduces their exposure to air-borne bacteria in the OR and eliminates their contamination through repetitive hospital sterilization. The short operation time and minimal blood loss achieved could also contribute to the reduction in infection risks. LEVEL OF EVIDENCE: Level II, prospective randomized bi-centric study.
Authors: Aakash Agarwal; Boren Lin; Jeffrey C Wang; Christian Schultz; Steve R Garfin; Vijay K Goel; Neel Anand; Anand K Agarwal Journal: Global Spine J Date: 2018-06-12
Authors: Daniel Karczewski; Klaus J Schnake; Georg Osterhoff; Ulrich Spiegl; Max J Scheyerer; Bernhard Ullrich; Matthias Pumberger Journal: Global Spine J Date: 2021-06-21
Authors: Aakash Agarwal; Christian Schultz; Vijay K Goel; Anand Agarwal; Neel Anand; Steve R Garfin; Jeffrey C Wang Journal: Global Spine J Date: 2018-04-24