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Spine (Phila Pa 1976). 2013 Dec 15;38(26):2227-39. doi: 10.1097/BRS.0000000000000031.

Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study.

Author information

1
*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.

Abstract

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.

PMID:
24335629
DOI:
10.1097/BRS.0000000000000031
[Indexed for MEDLINE]

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