640 - Cervical Arthroplasty vs. ACDF: Procedural Impact on Adjacent Level Su...

General Session: Cervical-2

Presented by: J. McConnell - View Audio/Video Presentation (Members Only)

Author(s):

J. McConnell(1), J. Highsmith(2), K. Baker(3), J. Myer(3)

(1) OAA Orthopaedic Specialists, Allentown, PA, United States
(2) Charleston Brain and Spine, Charleston, SC, United States
(3) Globus Medical, Inc., Audubon, PA, United States

Abstract

Purpose: Subsequent surgical intervention at adjacent levels is a risk associated with anterior cervical discectomy and fusion (ACDF) for the treatment of intractable cervical radiculopathy. Addressing this condition with a motion preservation device instead of ACDF may help reduce the risk of secondary surgery over several years.

Methods: A randomized, prospective, pivotal, IDE study of the SECURE®-C device was conducted at eighteen U.S. sites; data continued to be collected under a related postmarket study. In the IDE, patients were randomized 1:1 to either the investigational SECURE®-C disc or control ACDF, after five non-randomized training cases at each site were performed using SECURE®-C. Overall success was defined in the protocol as: 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 (control patients only). An alternate FDA definition of overall success required a 15 point improvement in NDI, stable or improved neurologic status, absence of device-related events, and no intraoperative change in treatment. Secondary outcome measures included: Visual Analog Scale (VAS) neck and arm pain, SF-36 Health Status Survey, adverse event rates and patient satisfaction. Outcome measures and radiographic evaluations were collected pre-operatively and at 6 weeks, 3, 6, 12 and 24 months and annually thereafter through 7 years postoperative.

Results: A total of 380 patients participated in the IDE study. Data is presented for patients as-treated; 88 non-randomized and 148 randomized subjects received SECURE®-C (236 total patients) and 144 received an ACDF. At 2 years postoperative, 1.7% (4/236) of SECURE®-C patients and 3.5% (5/144) of ACDF patients had subsequent surgery at one or more adjacent level(s). By 5 years postoperative, the rates increased to 2.5% (6/236) for the SECURE-C cohort and 11.8% (17/144) for ACDF cohort. At last follow-up of at least 7 years for all subjects, 4.2% (10/236) of SECURE-C patients underwent adjacent level surgery compared to 17.4% (25/144) of ACDF patients.

Conclusion: The rate of adjacent level surgery among patients treated with ACDF was more than four times that of patients treated with cervical arthroplasty. Motion preservation devices such as the SECURE®-C Cervical Artificial Disc are designed to allow physiologic motion of the operative level, essentially avoiding the disruption of motion characteristics that is inherent to ACDF. SECURE®-C is shown to reduce the risk of adjacent level surgery in the cervical spine compared to ACDF, as evidenced by long term clinical data.