Study Design. Prospective, multicenter, randomized, and controlled Investigational Device Exemption clinical trial.
Objective. To compare the clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, PA) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF).
Summary of Background Data. Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion. Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation.
Methods. A total of 380 patients from 18 investigational sites were prospectively enrolled in the study. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Clinical outcomes include overall success, visual analogue scale pain (right arm, left arm, and neck), neck disability index, neurological status, Short Form 36 (SF-36) Health Status Survey questionnaires, range of motion, and adverse events. Bayesian statistical methods were used to analyze the outcomes.
Results. Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at 24 months, with a posterior probability of 100% using the protocol-specified criteria and 98.1% using Food and Drug Administration-defined criteria. At 24 months postoperatively, SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index, visual analogue scale, and 36-Item Short Form Health Survey. At 24 months, the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group (2.5%) than the ACDF group (9.7%). At 24 months, 84.6% of as-treated SECURE-C patients were range-of-motion successes. Satisfaction was high among SECURE-C patients.
Conclusion. The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care, an anterior cervical discectomy and fusion. SECURE-C is statistically superior in terms of overall success, index-level subsequent surgical procedures, and patient satisfaction, making it an attractive surgical option for patients with symptomatic cervical disc disease.
Level of Evidence: 1
The prospective, randomized clinical trial demonstrates that the selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as an anterior cervical discectomy and fusion. SECURE-C is statistically superior in terms of overall success, subsequent surgical procedures at the index level, and patient satisfaction, at 24 months postoperatively, making it an attractive surgical option.
*Rothman Institute, Philadelphia, PA
†Pennsylvania Spine Institute, Harrisburg, PA
‡Trident Regional Medical Center, Charleston, SC
§Paradigm Biostatistics LLC, Anoka, MN
¶StatTech Services LLC, Chapel Hill, NC; and
‖Globus Medical, Audubon, PA.
Address correspondence and reprint requests to Kelly J. Baker, PhD, Globus Medical Inc, 2560 General Armistead Ave, Audubon, PA 19403; E-mail: email@example.com
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
No funds were received in support of this work.
Relevant financial activities outside the submitted work: consulting fee or honorarium, board membership, consultancy, grants/grants pending, royalties, stock/stock options, payment for development of educational presentations, and payment for writing or reviewing the manuscript.