Publications by authors named "Paul McAfee"

Eighty consecutive complex spinal robotic cases utilizing intraoperative 3D CT imaging (E3D, Group 2) were compared to 80 age-matched controls using the Excelsius robot alone with C-arm Fluoroscopic registration (Robot Only, Group 1). The demographics between the two groups were similar-severity of deformity, ASA Score for general anesthesia, patient age, gender, number of spinal levels instrumented, number of patients with prior spinal surgery, and amount of neurologic compression. The intraoperative CT scanning added several objective factors improving patient safety.

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Robotic navigation has been shown to increase precision, accuracy, and safety during spinal reconstructive procedures. There is a paucity of literature describing the best techniques for robotic-assisted spine surgery for complex, multilevel cases or in cases of significant deformity correction. We present a case series of 100 consecutive multilevel posterior spinal fusion procedures performed for multilevel spinal disease and/or deformity correction.

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Study Design: This is a retrospective cohort study.

Objectives: Pre and postop Measurement Testing. This is a retrospective study of 33 consecutive interbody spacers in 21 patients who underwent pre, intra, and postoperative measurement of the middle column to determine if this would lead to more precise restoration of middle column height and spacer fit.

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Study Design: An human cadaveric biomechanics study.

Objective: A proof-of-concept study to quantify whether or not differences in segmental mobility associated with spinal instability could be detected by a robotic distraction system.

Methods: Testing was performed in fresh human cadaveric tissue.

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Background: The optoelectronic camera source and data interpolation serve as the foundation for navigational integrity in the robotic-assisted surgical platform. The objective of the current systematic review serves to provide a basis for the numerical disparity that exists when comparing the intrinsic accuracy of optoelectronic cameras: accuracy observed in the laboratory setting versus accuracy in the clinical operative environment. It is postulated that there exists a greater number of connections in the optoelectronic kinematic chain when analyzing the clinical operative environment to the laboratory setting.

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Background: Middle-column gap balancing (MCGB) is a reference measurement of the path of the posterior longitudinal ligament (PLL), which is reconstructed under tension and balanced by the combined height of the posterior one-third of the vertebral bodies and the posterior one-third of the disks, including any intervening load-sharing spacers. This measurement allows for a comparison of the ligamentous component of the middle column (PLL) with the load-sharing components (posterior one-third vertebral body + disk ). This difference gives rise to a "middle-column mismatch," which provides a linear measurement of the redundancy of the ligaments and neural elements, which relates to the correct cage, spacer, or load-bearing height, which is optimized.

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Study Design: Benchtop model with prospective surgeon video testing.

Objective: To create a surface bleeding severity scale, the SPOT GRADE (SG), for quantitative assessment of target bleeding site (TBS) blood loss. This is of particular interest for spinal surgery due to epidural bleeding and an inability to use diathermy and radiofrequency cautery close to nerve roots.

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Study Design: This was a prospective, randomized, controlled, multicenter study.

Objective: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant.

Summary Of Background Data: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures.

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Study Design: Prospective, multicenter, randomized clinical trial.

Objective: To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.

Summary Of Background Data: The 2-year results of the PCM Cervical Disc trial have been reported previously.

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Purpose: Anterior plate fixation has been reported to provide satisfactory results in cervical spine distractive flexion (DF) injuries stages 1 and 2, but will result in a substantial failure rate in more unstable stage 3 and above. The aim of this investigation was to determine the biomechanical properties of different fixation techniques in a DF-3 injury model where all structures responsible for the posterior tension band mechanism are torn.

Methods: The multidirectional three-dimensional stiffness of the subaxial cervical spine was measured in eight cadaveric specimens with a simulated DF-3 injury at C5-C6, stabilized with four different fixation techniques: anterior plate alone, anterior plate combined with posterior wire, transarticular facet screws, and a pedicle screw-rod construct, respectively.

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Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.

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Background Context: Although multiple mechanisms of device attachment to the spinous processes exist, there is a paucity of data regarding lumbar spinous process morphology and peak failure loads.

Purpose: Using an in vitro human cadaveric spine model, the primary objective of the present study was to compare the peak load and mechanisms of lumbar spinous process failure with variation in spinous process hole location and pullout direction. A secondary objective was to provide an in-depth characterization of spinous process morphology.

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Alternatives to conventional rigid fusion have been proposed for several conditions related to degenerative disc disease when nonoperative treatment has failed. Semirigid fixation, in the form of dynamic stabilization or PEEK rods, is expected to provide compression under loading as well as an intermediate level of stabilization. This study systematically examines both the load-sharing characteristics and kinematics of these two devices compared to the standard of internal rigid fixators.

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Object: The introduction and utilization of motion-preserving implant systems for spinal reconstruction served as the impetus for this basic scientific investigation. The effect of unintended wear particulate debris resulting from micromotion at spinal implant interconnections and bearing surfaces remains a clinical concern. Using an in vivo rabbit model, the current study quantified the neural and systemic histopathological responses following epidural application of 11 different types of medical-grade particulate wear debris produced from spinal instrumentation.

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Study Design: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial.

Objective: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1.

Summary Of Background Data: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series.

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Background: This is a retrospective review of 25 patients with severe lumbar nerve root compression undergoing multilevel anterior retroperitoneal lumbar interbody fusion and posterior instrumentation for deformity. The objective is to analyze the outcomes and clinical results from anterior interbody fusions performed through a lateral approach and compare these with traditional surgical procedures.

Methods: A consecutive series of 25 patients (78 extreme lateral interbody fusion [XLIF] levels) was identified to illustrate the primary advantages of XLIF in correcting the most extreme of the 3-dimensional deformities that fulfilled the following criteria: (1) a minimum of 40° of scoliosis; (2) 2 or more levels of translation, anterior spondylolisthesis, and lateral subluxation (subluxation in 2 planes), causing symptomatic neurogenic claudication and severe spinal stenosis; and (3) lumbar hypokyphosis or flat-back syndrome.

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Study Design: This in vitro human cadaveric study measured adjacent-level kinematics after posterior cervical decompression and fixation.

Objective: Quantify adjacent-level changes in range of motion (ROM) and intradiscal pressure after posterior cervical decompression and fixation.

Summary Of Background Data: Optimal length of instrumentation after posterior decompression is unclear.

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Anterior cervical diskectomy and fusion for neurologic deficits, radicular arm pain, and neck pain refractory to conservative management are successful. The approach and procedure were first described in 1955 and have become the anterior cervical standard of care for orthopedic surgeons and neurosurgeons. Advancements and innovations have addressed disease processes of the cervical spine with motion-preserving technology.

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Study Design: Meta-analysis of 4 prospective randomized controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials.

Objective: To maximize the information available from 4 IDE studies by analyzing the combined outcomes of cervical arthroplasty versus fusion at 24-month follow-up.

Summary Of Background Data: To date, 4 randomized clinical trials have been completed in the United States under FDA IDE protocols to study cervical arthroplasty.

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Study Design: A retrospective review of patients treated at 2 institutions with anterior lumbar interbody fusion using a minimally invasive lateral retroperitoneal approach, and review of literature.

Objective: To analyze the outcomes from historical literature and from a retrospectively compiled database of patients having undergone anterior interbody fusions performed through a lateral approach.

Summary Of Background Data: A paucity of published literature exists describing outcomes following lateral approach fusion surgery.

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