Dataset Information

The Barrow Biomimetic Spine: Face, Content, and Construct Validity of a 3D-Printed Spine Model for Freehand and Minimally Invasive Pedicle Screw Insertion.

ABSTRACT:

Study design

Description and evaluation of a novel surgical training platform.

Objectives

The purpose of this study was to investigate the face, content, and construct validity of 5 novel surgical training models that simulate freehand and percutaneous (minimally invasive surgery [MIS]) pedicle screw placement.

Methods

Five spine models were developed by residents: 3 for freehand pedicle screw training (models A-C) and 2 for MIS pedicle screw training (models D and E). Attending spine surgeons evaluated each model and, using a 20-point Likert-type scale, answered survey questions on model face, content, and construct validity. Scores were statistically evaluated and compared using means, standard deviations, and analysis of variance between models and between surgeons.

Results

Among the freehand models, model C demonstrated the highest overall validity, with mean face (15.67 ± 5.49), content (19.17 ± 0.59), and construct (18.83 ± 0.24) validity all measuring higher than the other freehand models. For the MIS models, model D had the highest validity scores (face, content, and construct validity of 11.67 ± 3.77, 18.17 ± 2.04, and 17.00 ± 3.46, respectively). The 3 freehand models differed significantly in content validity scores (P = .002) as did the 2 MIS models (P < .001). The testing surgeons' overall validity scores were significantly different for models A (P = .005) and E (P < .001).

Conclusions

A 3-dimensional-printed spine model with incorporated bone bleeding and silicone rubber soft tissue was scored as having very high content and construct validity for simulating freehand pedicle screw insertion. These data has informed the further development of several surgical training models that hold great potential as educational adjuncts in surgical training programs.

SUBMITTER: Bohl MA

PROVIDER: S-EPMC6693063 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

The Barrow Biomimetic Spine: Face, Content, and Construct Validity of a 3D-Printed Spine Model for Freehand and Minimally Invasive Pedicle Screw Insertion.

Bohl Michael A MA Mauria Rohit R Zhou James J JJ Mooney Michael A MA DiDomenico Joseph D JD McBryan Sarah S Cavallo Claudio C Nakaji Peter P Chang Steve W SW Uribe Juan S JS Turner Jay D JD Kakarla U Kumar UK

Global spine journal 20190205 6

<h4>Study design</h4>Description and evaluation of a novel surgical training platform.<h4>Objectives</h4>The purpose of this study was to investigate the face, content, and construct validity of 5 novel surgical training models that simulate freehand and percutaneous (minimally invasive surgery [MIS]) pedicle screw placement.<h4>Methods</h4>Five spine models were developed by residents: 3 for freehand pedicle screw training (models A-C) and 2 for MIS pedicle screw training (models D and E). Atte ...[more]

PMID: 31448198

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Project description:This systematic review and meta-analysis investigated differences in accuracy, operation time, and radiation exposure time between robot-assisted and freehand techniques for pedicle screw insertion. Two investigators independently searched for articles on randomized controlled trials (RCTs) published from 2012 to 2019. The final meta-analysis included seven RCTs. We compared the accuracy of pedicle screw placement, operation time, and radiation exposure time between robot-assisted and conventional freehand groups. Seven RCTs included 540 patients and placement of 2,476 pedicle screws, of which 1,220 were inserted using the robot-assisted technique and 1,256 were inserted using the conventional freehand technique. The pedicle screw positions were classified using the Gertzbein and Robbins classification (grade A-E). The combined results of Grade A [odds ratio (OR) =1.68; 95% confidence intervals (CI): 0.82-3.44; P=0.16), Grade A+B (OR =1.70; 95% CI: 0.47-6.13; P=0.42), and Grade C+D+E (OR =0.59; 95% CI: 0.16-2.12; P=0.42) for the accuracy rate revealed no significant difference between the two groups. Subgroup analysis results revealed that the TiRobot-assisted technique presented a significantly improved pedicle screw insertion accuracy rate compared with that of the conventional freehand technique, based on Grade A, Grade A+B, and Grade C+D+E classifications. The SpineAssist-assisted technique presented an inferior pedicle screw insertion accuracy rate compared with that of the conventional freehand technique, based on Grade A, Grade A+B, and Grade C+D+E classifications. No difference between the Renaissance-assisted and conventional freehand techniques was noted for pedicle screw insertion accuracy rates, based on both Grade A (OR =1.58; 95% CI: 0.85-2.96; P=0.15), Grade A+B (OR =2.20; 95% CI: 0.39-12.43; P=0.37), and Grade C+D+E (OR =0.45; 95% CI: 0.08-2.56; P=0.37) classifications. Regarding operation time, robot-assisted surgery had significantly longer operation time than conventional freehand surgery. The robot-assisted group had significantly shorter radiation exposure time. Regarding the pedicle screw insertion accuracy rate, the TiRobot-assisted technique was superior, the SpineAssist-assisted technique was inferior, and Renaissance was similar to the conventional freehand technique.

Project description:PurposePedicle screw fixation in the upper cervical spine is a difficult and high-risk procedure. The screw is difficult to place rapidly and accurately, and can lead to serious injury of spinal cord or vertebral artery. The aim of this study was to design an individualized 3D printing navigation template for pedicle screw fixation in the upper cervical spine.MethodsUsing CT thin slices data, we employed computer software to design the navigation template for pedicle screw fixation in the upper cervical spine (atlas and axis). The upper cervical spine models and navigation templates were produced by 3D printer with equal proportion, two sets for each case. In one set (Test group), pedicle screws fixation were guided by the navigation template; in the second set (Control group), the screws were fixed under fluoroscopy. According to the degree of pedicle cortex perforation and whether the screw needed to be refitted, the fixation effects were divided into 3 types: Type I, screw is fully located within the vertebral pedicle; Type II, degree of pedicle cortex perforation is <1 mm, but with good internal fixation stability and no need to renovate; Type III, degree of pedicle cortex perforation is >1 mm or with the poor internal fixation stability and in need of renovation. Type I and Type II were acceptable placements; Type III placements were unacceptable.ResultsA total of 19 upper cervical spine and 19 navigation templates were printed, and 37 pedicle screws were fixed in each group. Type I screw-placements in the test group totaled 32; Type II totaled 3; and Type III totaled 2; with an acceptable rate of 94.60%. Type I screw placements in the control group totaled 23; Type II totaled 3; and Type III totaled 11, with an acceptable rate of 70.27%. The acceptability rate in test group was higher than the rate in control group. The operation time and fluoroscopic frequency for each screw were decreased, compared with control group.ConclusionThe individualized 3D printing navigation template for pedicle screw fixation is easy and safe, with a high success rate in the upper cervical spine surgery.

Project description:BackgroundThe anterior pedicle screw (APS) technique for L5 and S1 is crucial for proper anterior lumbar interbody fusion (ALIF). This study aimed to determine the projection, screw trajectory angle, and bone screw passageway length (BSPL), as well as the screw insertion regularity and the operating area within which it is safe to perform insertion.MethodsForty patients with low back pain, all of whom had lumbar computed tomography scans available, was included in this retrospective analysis. Radiographic parameters were measured, including: the distances from the projection to the upper endplate, lower endplate, and midline; the transverse and sagittal screw angles; and the BSPL. In addition, 10 fresh adult cadaveric lumbosacral spine segments were selected to determine the safe anatomic area in which to operate. Finally, APSs were inserted in L5 and S1 to determine the regularity of APS insertion.ResultsWe measured the anterior projection parameters, including: the distances to the upper endplate (L5: 12.5±1.3 mm; S1: 4.54±0.87 mm), lower endplate (L5: 17.3±1.6 mm), and midline (L5: 6.6±0.7 mm; S1: 6.6±0.6 mm); the screw trajectory angle, including the transverse screw angle (L5: 25.3±2.8°; S1: 25.7±2.6°), sagittal screw angle (L5: 17.1±1.7°; S1: 22.4±1.1°); and the BSPL (L5: 48.6±3.5 mm; S1: 48.0±3.5 mm). The regularity of APS insertion in L5 and S1 was determined. Upon the needle reaching a point in the lateral view, it reached the corresponding point in the anteroposterior (AP) view. The anatomic parameters of the safe operating area were as follows: the distance from the abdominal aortic bifurcation to the L5 lower edge (40.50±9.40 mm); the distance from the common iliac vein confluence to the L5 lower edge (27.80±8.60 mm); and the horizontal distance from the inner edge of the common iliac vein to the L5 lower edge (37.50±1.30 mm). We also determined the distance between S1 holes (29.30±1.30 mm), the L5/S1 intervertebral height (17.20±1.50 mm), and the safe operating area (2,058.20±84.30 mm2).ConclusionsThis study has determined the projection, screw trajectory angle, and BSPL of APSs in L5 and S1, their insertion regularity, and the area in which the operation can be safely performed.

Project description:PurposeA hybrid pedicle screw system for minimally invasive spinal fixation was developed based on the uniplanar pedicle screw construct and a new intermediate screw. Its biomechanical performance was evaluated using finite element (FE) analysis.MethodsA T12-L2 FE model was established to simulate the L1 vertebral compression fracture with Magerl classification A1.2. Six fixation models were developed to simulate the posterior pedicle screw fracture fixation, which were divided into two subgroups with different construct configurations: (1) six-monoaxial/uniplanar/polyaxial pedicle screw constructs and (2) four-monoaxial/uniplanar/polyaxial pedicle screw constructs with the new intermediate screw. After model validation, flexion, extension, lateral bending, and axial rotation with 7.5 Nm moments and preloading of 500 N vertical compression were applied to the FE models to compare the biomechanical performances of the six fixation models with maximum von Mises stress, range of motion, and maximum displacement of the vertebra.ResultsUnder four loading scenarios, the maximum von Mises stresses were found to be at the roots of the upper or lower pedicle screws. In the cases of flexion, lateral bending, and axial rotation, the maximum von Mises stress of the uniplanar screw construct lay in between the monoaxial and polyaxial screw constructs in each subgroup. Considering lateral bending, the uniplanar screw construct enabled to lower the maximum von Mises stress than monoaxial and polyaxial pedicle screw constructs in each subgroup. Two subgroups showed comparable results of the maximum von Mises stress on the endplates, range of motion of T12-L1, and maximum displacement of T12 between the corresponding constructs with the new intermediate screw or not.ConclusionsThe observations shown in this study verified that the hybrid uniplanar pedicle screw system exhibited comparable biomechanical performance as compared with other posterior short-segment constructs. The potential advantage of this new fixation system may provide researchers and clinical practitioners an alternative for minimally invasive spinal fixation with vertebral augmentation.

Project description:PurposeMinimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is increasingly popular for the surgical treatment of degenerative lumbar disc diseases. The constructs intended for segmental stability are varied in MI-TLIF. We adopted finite element (FE) analysis to compare the stability after different construct fixations using interbody cage with posterior pedicle screw-rod or pedicle screw-plate instrumentation system.MethodsA L3-S1 FE model was modified to simulate decompression and fusion at L4-L5 segment. Fixation modes included unilateral plate (UP), unilateral rod (UR), bilateral plate (BP), bilateral rod (BR) and UP+UR fixation. The inferior surface of the S1 vertebra remained immobilized throughout the load simulation, and a bending moment of 7.5 Nm with 400N pre-load was applied on the L3 vertebra to recreate flexion, extension, lateral bending, and axial rotation. Range of motion (ROM) and Von Mises stress were evaluated for intact and instrumentation models in all loading planes.ResultsAll reconstructive conditions displayed decreased motion at L4-L5. The pedicle screw-plate system offered equal ROM to pedicle screw-rod system in unilateral or bilateral fixation modes respectively. Pedicle screw stresses for plate system were 2.2 times greater than those for rod system in left lateral bending under unilateral fixation. Stresses for plate were 3.1 times greater than those for rod in right axial rotation under bilateral fixation. Stresses on intervertebral graft for plate system were similar to rod system in unilateral and bilateral fixation modes respectively. Increased ROM and posterior instrumentation stresses were observed in all loading modes with unilateral fixation compared with bilateral fixation in both systems.ConclusionsTransforaminal lumbar interbody fusion augmentation with pedicle screw-plate system fixation increases fusion construct stability equally to the pedicle screw-rod system. Increased posterior instrumentation stresses are observed in all loading modes with plate fixation, and bilateral fixation could reduce stress concentration.

Dataset Information

The Barrow Biomimetic Spine: Face, Content, and Construct Validity of a 3D-Printed Spine Model for Freehand and Minimally Invasive Pedicle Screw Insertion.

Study design

Objectives

Methods

Results

Conclusions

Publications

The Barrow Biomimetic Spine: Face, Content, and Construct Validity of a 3D-Printed Spine Model for Freehand and Minimally Invasive Pedicle Screw Insertion.

Similar Datasets

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