scholarly journals Patient-specific template-guided versus standard freehand lumbar pedicle screw implantation: a randomized controlled trial

2021 ◽  
pp. 1-7
Author(s):  
José Miguel Spirig ◽  
Shayan Golshani ◽  
Nadja A. Farshad-Amacker ◽  
Mazda Farshad
Keyword(s):  
Randomized Controlled Trial ◽  
Radiation Exposure ◽  
Pedicle Screw ◽  
Controlled Trial ◽  
Patient Specific ◽  
Pedicle Screw Placement ◽  
Surgical Time ◽  
Screw Insertion ◽  
Pedicle Screw Insertion ◽  
Randomized Controlled

OBJECTIVE Patient-specific template-guided (TG) pedicle screw placement currently achieves the highest reported accuracy in cadaveric and early clinical studies, with reports of reduced use of radiation and less surgical time. However, a clinical randomized controlled trial (RCT) eliminating potential biases is lacking. This study compares TG and standard freehand (FH) pedicle screw insertion techniques in an RCT. METHODS Twenty-four patients (mean age 64 years, 9 men and 15 women) scheduled consecutively and independently from this study for 1-, 2-, or 3-level lumbar fusion were randomized to either the FH (n = 12) or TG (n = 12) group. Accuracy of pedicle screw placement, intraoperative parameters, and short-term complications were compared. RESULTS A total of 112 screws (58 FH and 54 TG screws) were implanted in the lumbar spine. Radiation exposure was significantly less in the TG group (78.0 ± 46.3 cGycm2) compared with the FH group (234.1 ± 138.1 cGycm2, p = 0.001). There were 4 pedicle screw perforations (6.9%) in the FH group and 2 (3.7%) in the TG group (p > 0.99), with no clinical consequences. Clinically relevant complications were 1 postoperative pedicle fracture in the FH group (p > 0.99), 1 infection in the FH group, and 2 infections in the TG group (p > 0.99). There were no significant differences in surgical exposure time, screw insertion time, overall surgical time, or blood loss between the FH and TG groups. CONCLUSIONS In this RCT, patient-specific TG pedicle screw insertion in the lumbar region achieved a high accuracy, but not better than a standardized FH technique. Even if intraoperative radiation exposure is less with the TG technique, the need for a preoperative CT scan counterbalances this advantage. However, more difficult trajectories might reveal potential benefits of the TG technique and need further research.

scholarly journals Accuracy assessment of pedicle screw insertion with patient specific 3D‑printed guides through superimpose CT-analysis in thoracolumbar spinal deformity surgery

2021 ◽  
Author(s):  
J. Cool ◽  
J. van Schuppen ◽  
M. A. de Boer ◽  
B. J. van Royen
Keyword(s):  
Pedicle Screw ◽  
Spinal Deformity ◽  
Screw Placement ◽  
Patient Specific ◽  
Pedicle Screw Placement ◽  
Screw Insertion ◽  
Pedicle Screw Insertion ◽  
Spinal Deformity Surgery ◽  
Ct Analysis ◽  
3D Printed

Abstract Purpose In order to avoid pedicle screw misplacement in posterior spinal deformity surgery, patient specific 3D‑printed guides can be used. An accuracy assessment of pedicle screw insertion can be obtained by superimposing CT-scan images from a preoperative plan over those of the postoperative result. The aim of this study is to report on the accuracy of drill guide assisted pedicle screw placement in thoracolumbar spinal deformity surgery by means of a superimpose CT-analysis. Methods Concomitant with the clinical introduction of a new technique for drill guide assisted pedicle screw placement, the accuracy of pedicle screw insertion was analyzed in the first patients treated with this technique by using superimpose CT-analysis. Deviation from the planned ideal intrapedicular screw trajectory was classified according to the Gertzbein scale. Results Superimpose CT-analysis of 99 pedicle screws in 5 patients was performed. The mean linear deviation was 0.92 mm, the mean angular deviation was 2.92° with respect to the preoperatively planned pedicle screw trajectories. According to the Gertzbein scale, 100% of screws were found to be positioned within the “safe zone”. Conclusion The evaluated patient specific 3D-printed guide technology was demonstrated to constitute a safe and accurate tool for precise pedicle screw insertion in spinal deformity surgeries. Superimpose CT-analysis showed a 100% accuracy of pedicle screw placement without any violation of the pedicle wall or other relevant structures. We recommend a superimpose CT-analysis for the first consecutive patients when introducing new technologies into daily clinical practice, such as intraoperative imaging, navigation or robotics.

scholarly journals Pedicle screw placement accuracy using ultra-low radiation imaging with image enhancement versus conventional fluoroscopy in minimally invasive transforaminal lumbar interbody fusion: an internally randomized controlled trial

2018 ◽  
Vol 28 (2) ◽  
pp. 186-193 ◽  
Author(s):  
Gautam Nayar ◽  
Daniel J. Blizzard ◽  
Timothy Y. Wang ◽  
Steven Cook ◽  
Adam G. Back ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pedicle Screw ◽  
Image Enhancement ◽  
Imaging Modality ◽  
Controlled Trial ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Screw Placement ◽  
Pedicle Screw Placement ◽  
Operating Room Personnel ◽  
Randomized Controlled

OBJECTIVEA previous study found that ultra-low radiation imaging (ULRI) with image enhancement significantly decreases radiation exposure by roughly 75% for both the patient and operating room personnel during minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) (p < 0.001). However, no clinical data exist on whether this imaging modality negatively impacts patient outcomes. Thus, the goal of this randomized controlled trial was to assess pedicle screw placement accuracy with ULRI with image enhancement compared with conventional, standard-dose fluoroscopy for patients undergoing single-level MIS-TLIF.METHODSAn institutional review board–approved, prospective internally randomized controlled trial was performed to compare breach rates for pedicle screw placement performed using ULRI with image enhancement versus conventional fluoroscopy. For cannulation and pedicle screw placement, surgery on 1 side (left vs right) was randomly assigned to be performed under ULRI. Screws on the opposite side were placed under conventional fluoroscopy, thereby allowing each patient to serve as his/her own control. In addition to standard intraoperative images to check screw placement, each patient underwent postoperative CT. Three experienced neurosurgeons independently analyzed the images and were blinded as to which imaging modality was used to assist with each screw placement. Screw placement was analyzed for pedicle breach (lateral vs medial and Grade 0 [< 2.0 mm], Grade 1 [2.0–4.0 mm], or Grade 2 [> 4.0 mm]), appropriate screw depth (50%–75% of the vertebral body’s anteroposterior dimension), and appropriate screw angle (within 10° of the pedicle angle). The effective breach rate was calculated as the percentage of screws evaluated as breached > 2.0 mm medially or postoperatively symptomatic.RESULTSTwenty-three consecutive patients underwent single-level MIS-TLIF, and their sides were randomly assigned to receive ULRI. No patient had immediate postoperative complications (e.g., neurological decline, need for hardware repositioning). On CT confirmation, 4 screws that had K-wire placement and cannulation under ULRI and screw placement under conventional fluoroscopy showed deviations. There were 2 breaches that deviated medially but both were Grade 0 (< 2.0 mm). Similarly, 2 breaches occurred that were Grade 1 (> 2.0 mm) but both deviated laterally. Therefore, the effective breach rate (breach > 2.0 mm deviated medially) was unchanged in both imaging groups (0% using either ULRI or conventional fluoroscopy; p = 1.00).CONCLUSIONSULRI with image enhancement does not compromise accuracy during pedicle screw placement compared with conventional fluoroscopy while it significantly decreases radiation exposure to both the patient and operating room personnel.

Radiation Exposure During Fluoroscopically-Assisted Pedicle Screw Insertion

Neurosurgery ◽  
1999 ◽  
Vol 45 (3) ◽  
pp. 710-711
Author(s):  
Kevin Foley ◽  
Y. Raja Rampersaud ◽  
Alfred C. Shen ◽  
Scott Williams ◽  
Milo Solomito
Keyword(s):  
Radiation Exposure ◽  
Pedicle Screw ◽  
Screw Insertion ◽  
Pedicle Screw Insertion

scholarly journals Radiation Exposure during Fluoroscopic Assistance for Pedicle Screw Insertion during Instrumented Spine Surgery

2015 ◽  
Vol 5 (1_suppl) ◽  
pp. s-0035-1554581-s-0035-1554581
Author(s):  
José Vicente Ballesteros Plaza ◽  
Ratko Jovan Yurac Barrientos ◽  
Enrique Andrés Viveros Pereira
Keyword(s):  
Radiation Exposure ◽  
Pedicle Screw ◽  
Spine Surgery ◽  
Screw Insertion ◽  
Pedicle Screw Insertion ◽  
Instrumented Spine Surgery

scholarly journals Feasibility and Efficacy of a Decision Aid for Emergency Department Patients with Suspected Ureterolithiasis: Protocol for an Adaptive Randomized Controlled Trial

2021 ◽  
Author(s):  
Elizabeth M Schoenfeld ◽  
Kye E Poronsky ◽  
Lauren M Westafer ◽  
Paul Visintainer ◽  
Brianna M DiFronzo ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Ct Scan ◽  
Radiation Exposure ◽  
Kidney Stone ◽  
Decision Aid ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Patient Knowledge ◽  
Randomized Controlled

Abstract Background: Approximately 2 million patients present to Emergency Departments in the US annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization. Methods: This is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention – a decision aid (“Kidney Stone Choice”) – on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the Emergency Department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization. Discussion: We hypothesize that this study will demonstrate that “Kidney Stone Choice,” the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy. Trial registration: ClinicalTrials.gov - NCT04234035https://clinicaltrials.gov/ct2/show/NCT04234035Registered January 21, 2020 – Retrospectively Registered

Radiation Exposure to the Spine Surgeon During Fluoroscopically Assisted Pedicle Screw Insertion

Spine ◽  
2000 ◽  
Vol 25 (20) ◽  
pp. 2637-2645 ◽  
Author(s):  
Y. Raja Rampersaud ◽  
Kevin T. Foley ◽  
Alfred C. Shen ◽  
Scott Williams ◽  
Milo Solomito
Keyword(s):  
Radiation Exposure ◽  
Pedicle Screw ◽  
Screw Insertion ◽  
Pedicle Screw Insertion ◽  
Spine Surgeon
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