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Sponsored by: |
Globus Medical Inc |
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Information provided by: | Globus Medical Inc |
ClinicalTrials.gov Identifier: | NCT00882661 |
The purpose of the study is to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.
Condition | Intervention | Phase |
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Symptomatic Cervical Disc Disease |
Device: SECURE-C Cervical Artificial Disc Procedure: Anterior Cervical Discectomy and Fusion (ACDF) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study |
Enrollment: | 380 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: 18 to 60 years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Globus Medical Inc ( Kelly Baker, PhD, Director, Regulatory and Clinical Affairs ) |
Study ID Numbers: | GPR002 |
Study First Received: | April 14, 2009 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00882661 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neck Pain Arm Pain |
Neck Pain Pain |