A Prospective Multicenter Trial of an Expandable Graft-Containing Fabric Mesh System for Minimally Invasive Single-Level Lumbar Interbody Stabilization: Updates on the Spineology Clinical Outcomes Trial (SCOUT)

Presented at SMISS Annual Forum 2018
By K. Huang
With Jorge Isaza MD, Kee Kim MD, Raphael Roybal MD, Cyrus Ghavam MD, Samuel Joseph MD, Matthew McGirt MD,

Disclosures: K. Huang None Jorge Isaza MD B; MiRus, LLC, Globus, Zimmer-Biomet, SI-Bone, Republic Spine. F; Globus, Zimmer-Biomet., Kee Kim MD A; Medtronic, Empirical Spine, Orthofix, Vertex, Mesoblast, Zimmer-Biomet, In-Vivo, Fziomed, Seikagaku, Pacira. B; MiRus, LLC, AO Spine, Vertex, In-Vivo, Corentec, Globus, Zimmer-Biomet. F; Zimmer-Bio, Raphael Roybal MD B; MiRus, LLC. C; K2M. D; MiRus, LLC. F; Orthofix., Cyrus Ghavam MD B; Precision Spine. D; MiRus, LLC., Samuel Joseph MD B; Stryker, Medacta, MiRus, LLC., Matthew McGirt MD B; MiRus, LLC, Stryker.,

Introduction:

Surgical options continue to advance for patients with medically-refractory lumbar degenerative disc disease and spondylolisthesis. Current interbody fusion techniques with rigid cages are well-known to spine surgeons, but necessitate a degree of soft-tissue dissection and bone removal.

Aims/Objectives:

The SCOUT study is an ongoing FDA IDE trial investigating the safety and efficacy of a novel device for lumbar interbody fusion. It is an expandable bone graft-containing fabric mesh that can be deployed through a delivery portal only 8mm in diameter. We report here on interval follow-up results.

Methods:

Patients were enrolled in a prospective, single-arm trial at nine different investigational sites starting in 2015. Patients selected for the study were skeletally mature adults, ages 21 to 80, who had single-level symptomatic lumbar degenerative disc disease (levels L2-S1) requiring interbody fusion. All patients had a minimum Visual Analogue Score (VAS) of 40mm (0-100 mm scale) and a minimum Oswestry Disability Index (ODI) of 40. All patients had a BMI < 40 and had failed at least 6 months of conservative therapy. Patients were excluded if they had multilevel disease, previous fusion at the affected level, or greater than Grade I spondylolisthesis. All patients underwent either a MIS-TLIF or open PLIF approach (chosen based on surgeon preference), and all received supplemental pedicle screw fixation.

Results:

At most recent follow-up, 102 patients had undergone surgery, with 88 completing 6-month follow-up and 72 completing 12-month follow-up. From a baseline VAS low back pain score of 74 ± 16 (Mean ± SD) and baseline ODI of 54 ± 12, there were significant improvements at both 6-months (VAS: 27 ± 27, ODI: 25 ± 21, p< 0.0001 for each) and 12-months (VAS: 22 ± 24, ODI: 21 ± 20, p< 0.0001 for each). Similarly, at 12-month follow-up, 43 (60%) patients reported “Excellent” satisfaction with their procedure and an additional 20 (28%) reported “Good” satisfaction, compared to 8 (11%) who reported “Fair” and 1 (1.4%) who reported “Poor” outcomes. At twelve-month follow-up, all 57 patients (100%) demonstrated radiographic fusion, as defined by evidence of bridging bone on CT scan by two independent radiologists. There were no serious device-related adverse events.

Conclusions:

There are encouraging results for the use of an expandable graft-containing fabric mesh system for use in lumbar interbody stabilization. Data from this prospective multicenter trial indicate the potential for these results to remain durable and favorable up through one-year follow-up.