General Session: Cervical Degenerative
Presented by: W. Beutler - View Audio/Video Presentation (Members Only)
W. Beutler(1), I. Volcan(2), P. Asdourian(3), J. Myer(4), K. Baker(4)
(1) Pennsylvania Spine Institute, Harrisburg, PA, United States
(2) West Augusta Spine Specialists, Augusta, GA, United States
(3) Greater Chesapeake Orthopedic Associates, Baltimore, MD, United States
(4) Globus Medical, Inc., Audubon, PA, United States
Purpose: Patient-reported outcome measures play a significant role in assessing the efficacy of new devices. An IDE study was conducted to evaluate the clinical performance of the SECURE®-C Cervical Artificial Disc as compared to anterior cervical discectomy and fusion (ACDF). Patient assessments were utilized to determine efficacy of this device for the treatment of symptomatic cervical disc disease. In this analysis, emphasis was placed on measures directly related to neck discomfort and cervical radiculopathy that record pain relief and assess functionality. Outcomes at 7 years post-op as compared to 2 years are evaluated.
Methods: The pivotal IDE study of the SECURE®-C device was conducted at eighteen U.S. sites; data continued to be collected under a postmarket follow up study. Criteria for study participation included symptomatic cervical disc disease in one vertebral level between C3 and C7, defined by neck and/or arm pain, herniated nucleus pulposus, radiculopathy or myelopathy, and other conditions as specified in the study protocol. All study patients have a preoperative Neck Disability Index (NDI) score of at least 30 (as a percentage of a 50 point total). Enrolled patients were randomized 1:1 to either the investigational SECURE®-C disc or control ACDF, with exception of the first five patients treated at each site who were non-randomized and received SECURE®-C. Patient-reported outcomes included NDI, Visual Analog Scale (VAS) and satisfaction recorded pre-operatively and at 6 weeks, 3, 6, 12 and 24 months and annually thereafter through 7 years postoperative. A total of 380 patients participated in the IDE; 151 patients were randomized to the investigational SECURE®-C device and 140 to control ACDF. Data on randomized patients are presented.
Results: There were 138 SECURE®-C and 115 ACDF patients in the 2 year cohort; 125 and 102 patients returned for 7 years follow up, respectively. Non-inferiority of SECURE-C as compared to ACDF was established for improvement in NDI and VAS (neck, right and left arm pain) scores at 2 years. At 7 years, non-inferiority was maintained for NDI and VAS neck pain; SECURE-C was shown to be superior to ACDF for improvement in VAS right and left arm pain (VAS success defined as 20mm improvement from baseline or a pain score of 0mm). Superiority in terms of patient satisfaction was achieved for SECURE-C compared to ACDF at 2 and 7 years. Figure 1 compares patient-reported outcomes preoperatively and at 2 and 7 years post-op for patients treated with SECURE®-C and ACDF.
Conclusions: Patient-reported outcomes are a direct reflection of the patient's clinical experience with and perception of an implanted device. These results confirm that improved functionality and pain relief are maintained through 7 years postoperative in patients treated with the SECURE-C Cervical Artificial Disc for symptomatic cervical disc disease.
Figure 1. Comparison of Patient-Reported Outcomes