General Session: Cervical-2
Presented by: J. McConnell - View Audio/Video Presentation (Members Only)
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
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.