389 - Does Preservation of Motion in the Cervical Spine after Treatment with...

#389 Does Preservation of Motion in the Cervical Spine after Treatment with the SECURE-C Artificial Disc Result in Fewer Subsequent Surgical Interventions?

Oral Posters: Cervical Arthroplasty

Presented by: J. McConnell

Author(s):

J. McConnell (1)
W.J. Beutler (2)
W.C. Peppelman (2)
J. Marzluff (3)
J. Highsmith (3)
J. Lindley (4)
K. Baker (5)
J. Myer (6)

(1) OAA Orthopaedic Specialists, Allentown, PA, USA
(2) Pennsylvania Spine Institute, Harrisburg, PA, USA
(3) Charleston Brain and Spine, Charleston, PA, USA
(4) Neurological Institute of Savannah, Savannah, PA, USA
(5) Globus Medical, Inc., Audubon, PA, USA
(6) Globus Medical, Inc., Clinical Affairs, Audubon, PA, USA

Abstract

Purpose: The rates of subsequent surgical intervention at the index level and radiographic outcomes for patients treated with a cervical arthroplasty device (SECURE®-C) and an anterior cervical discectomy and fusion (ACDF) were compared. Results are presented from 380 enrolled subjects, including the randomized and non-randomized cohorts.

Methods: A prospective, randomized pivotal IDE study of the SECURE®-C device (Globus Medical, Audubon, PA) was conducted at eighteen sites in the U.S. Enrolled patients were randomized 1:1 to either the investigational SECURE®-C disc or the control ACDF, with the first five patients at each site receiving the investigational treatment. This abstract presents patients as-treated; 88 non-randomized and 148 randomized patients (236 total) were treated with SECURE®-C, and 144 subjects were treated with ACDF, for a total of 380 patients treated in the study. Flexion-extension range of motion (ROM), translational ROM (during flexion-extension), and disc height at the index level was compared as well as the rate of subsequent surgical intervention at the index level. Results at 24 months (±2mo) and 60 months (±2mo) are reported.

Results: Flexion-extension ROM for patients treated with SECURE®-C was 8.5° ±4.8° pre-op and 9.3° ±5.9° at 24 months, and 8.9° ±12.5° at 60 months. For patients treated with ACDF, flexion-extension ROM was 7.2° ±4.3° pre-op and 0.7° ±0.7° at 24 months, and 0.5°±0.2° at 60 months. Translational ROM for SECURE®-C patients was 0.9° ±0.6° pre-op and 1.2° ±0.8° at 24 months and 1.1° ±1.5° at 60 months. In the control ACDF cohort, translational ROM was 0.8° ±0.6° pre-op and 0.1° ±0.1° at 24 months and 0.0° ±0.1° at 60 months. The disc height for SECURE®-C patients was 3.8 ±0.8mm pre-op and 5.7 ±1.0mm at 24 months, and 5.4 ±1.2mm at 60 months. For the ACDF cohort, the disc height was 3.7 ±0.7mm pre-op and 4.2 ±1.2mm at 24 months, and 4.9 ±0.5mm at 60 months. By 24 months, a total of four SECUREÒ-C investigational subjects had undergone subsequent surgery at the index level (3 removal and fusions, 1 posterior decompression). A total of 10 control ACDF patients had subsequent surgery at the index level (6 removed and replaced by either one-, two-, or three-level ACDF, 3 removals required due to adjacent level, 1 posterior decompression). By 60 months, two additional SECURE-C patients (1 removal and fusion, 1 posterior decompression) and 5 additional ACDF patients (5 removals required due to adjacent level) had index level surgery, resulting in a secondary surgery rate of 2.5% (6/236) for SECURE-C versus 10.4% (15/144) with ACDF.

Conclusion: Subsequent surgical intervention was necessary more frequently in patients treated with ACDF than the patients treated with the motion sparing SECURE®-C device. These results suggest that motion preservation devices such as the SECURE®-C Cervical Artificial Disc may help preserve physiologic motion and may reduce the risk of subsequent surgical interventions.