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P151. Two-year experience with fenestrated pedicle...
Journal article

P151. Two-year experience with fenestrated pedicle screw cement augmentation in spine surgery: a safety and efficacy study

Abstract

BACKGROUND CONTEXT Fenestrated pedicle screw cement augmentation (FPSCA) in spine surgery has recently been FDA approved in 2016. Although numerous biomechanical studies support its use to increase pull-out strength, few studies report its safety and efficacy in a broad scope of indications. PURPOSE Our goal was to report our practice pattern, perioperative outcomes and complications with a new FPSCA system. STUDY DESIGN/SETTING Retrospective cohort study. PATIENT SAMPLE Forty-three consecutive patients over 14 months. OUTCOME MEASURES Occurrence of hardware failure, cement leaks, cement embolism, fat embolism, mortality METHODS Forty-three patients underwent FPSCA (2.5mL of high viscosity polymethylmetacrylate per screw) between September 2017 and November 2018 by six surgeons at our institution for degenerative disease, tumor, trauma or deformity correction. Baseline demographics, bone density, operative data, perioperative outcome (failure rate), complications (cement embolus, pulmonary embolism, perivertebral cement leaks, mortality) and postoperative X-rays or computed tomography were reported. Our practice pattern was also reported (regional distribution and indications). RESULTS Average age was 64.9±17.6 years. Mean follow-up was 15.5±12.3 weeks. Twenty-three patients (53.5%) had osteoporosis or osteopenia; 175 cement-augmented pedicle screws were used in constructs totaling 276 screws (63.4%). Regional distribution was: thoracic (18%), lumbar (58.1%) and thoracolumbar (23.2%). Indication were: deformity (36.2%), tumor (24.9%), trauma (7%) and degenerative conditions (31.9%). Most augmentations were performed at a combination of the UIV, UIV –1 and LIV. Systematic verification of screw depth before injection prevented rod insertion difficulties. Complications comprised cement leakage (22 patients, 51.1%), hardware failure (4 patients, 9.3%) and non-cement related pulmonary embolism (two patients). Fifty-six leaks occurred and concerned segmental veins (38 leaks, 67.8%), basivertebral veins (8 leaks, 14.2%), a cortical defect (4 leaks, 9.3%) or the spinal canal (6 patients, 13.9%). None of the patients developed acute respiratory distress syndrome from fat embolism. No symptomatic cement embolism or perioperative cement-related death occurred. CONCLUSIONS This is the largest mixed-indication case-series on record in North America. Fenestrated pedicle screw augmentation in spine surgery can be a safe and effective method of increasing fixation in osteopenic bone. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Authors

Ratnayake R; Bouloussa H; Majid K; Kuo CC; Bains RS

Journal

The Spine Journal, Vol. 19, No. 9,

Publisher

Elsevier

Publication Date

September 1, 2019

DOI

10.1016/j.spinee.2019.05.576

ISSN

1529-9430

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