#416 SECURE®-C Cervical Artificial Disc IDE Clinical Trial: Outcomes at Two and Five Years

General Session: Cervical Motion Preservation

Presented by: W. Beutler

Author(s):

W.J. Beutler (1)
W.C. Peppelman (1)
J. Marzluff (2)
C. Tomaras (3)
I. Volcan (4)
P. Asdourian (5)
K. Baker (6)
J. Myer (6)

(1) Pennsylvania Spine Institute, Harrisburg, PA, USA
(2) Charleston Brain and Spine, Charleston, PA, USA
(3) Peachtree Neurosurgery, Atlanta, GA, USA
(4) West Augusta Spine Specialists, Augusta, GA, USA
(5) Greater Chespeake Orthopedic Associates, Baltimore, MD, USA
(6) Globus Medical, Inc., Audubon, PA, USA

Abstract

Purpose: An Investigational Device Exemption study was conducted to evaluate the safety and efficacy of the SECURE®-C Cervical Artificial Disc. Outcomes are presented at two and five years post-operative on randomized subjects.

Methods: The prospective, randomized study was conducted, at 18 U.S. sites, to compare results from patients treated with the investigational SECURE®-C (Globus Medical) to those receiving the control anterior cervical discectomy and fusion (ACDF). Patients were randomized 1:1 to SECURE®-C or ACDF. The first 5 non-randomized patients at each site received SECURE®-C. Per the approved protocol, overall success requires: pain/disability improvement of at least 25% in Neck Disability Index (NDI); no device failures requiring revision, re-operation or removal; absence of major complications; and radiographic fusion (ACDF). An alternate FDA definition of overall success requires: NDI improvement by 15 points, maintenance or improvement in neurologic status, absence of device-related events, and no intraoperative change in treatment. Secondary outcome measurements include Visual Analog Scale (VAS) neck and arm pain, SF-36 Health Survey, and patient satisfaction. Outcomes were collected preoperative, 6 weeks, 3, 6, 12, 24 months and annually through at least 5 years.

Results: Data is presented on 151 patients randomized to SECURE®-C and 140 patients randomized to ACDF. For SECURE®-C patients, average NDI improved from 51.8 ±13.8 pre-op to 13.2 ±17.8 at 24 months and 5.3 ±8.1 at 60 months, compared to 51.5 ±14.9 pre-op to 16.5 ±18.7 at 24 months and 14.6 ±16.0 at 60 months for ACDF patients. Mean VAS neck scores improved from 64.7 ±26.4 pre-op to 14.5 ±22.5 at 24 months and 8.0 ±20.0 at 60 months for SECURE®-C, and from 63.5 ±26.8 pre-op to 20.3 ±26.7 at 24 months and 22.7 ±26.4 at 60 months for ACDF. In SECURE®-C patients, mean VAS left arm scores improved from 44.8 ±37.1 pre-op to 8.9 ±20.5 at 24 months and 5.0 ±10.3 at 60 months and from 40.3 ±36.1 pre-op to 10.8 ±22.8 at 24 months and 6.2 ±14.9 at 60 months in ACDF. Mean VAS right arm scores improved from 33.8 ±36.9 pre-op to 6.6 ±17.5 at 24 months and 7.7 ±16.9 at 60 months for SECURE®-C and from 36.8 ±37.0 pre-op to 8.6 ±17.9 at 24 months and 11.7 ±26.7 at 60 months for ACDF. Overall success at 24 months was achieved for 90.1% of SECURE®-C patients according to the original protocol definition (83.8% using the alternate definition) and 71.1% of ACDF (73.2% alternate definition), demonstrating statistical superiority of SECURE-C compared to ACDF for both measures of overall success. Subsequent surgical intervention at the index level occurred in 3 SECURE®-C patients (2.0%) compared to 10 ACDF (6.9%) by 24 months in this randomized cohort (as-treated). By 60 months, the interventions increased to a cumulative total of 4 SECURE®-C (2.7%) and 15 ACDF patients (10.4%). There was no significant difference between the groups in terms of adverse event rate, or maintenance or improvement in neurologic status.

Conclusion: Study results suggest that SECURE®-C is a safe and effective treatment for symptomatic cervical disc disease, as an alternative to ACDF at 24 months. Results also suggest that the device remains a safe and effective treatment long term.