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Sponsored by: |
Orthofix, Inc. |
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Information provided by: | Orthofix, Inc. |
ClinicalTrials.gov Identifier: | NCT00637312 |
The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).
Condition | Intervention |
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Cervical Degenerative Disc Disease |
Device: Cervical Artificial Disc (Advent™ Cervical Disc) Device: ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease |
Estimated Enrollment: | 450 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Advent™ Cervical Disc
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Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
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2: Active Comparator
ACDF Control
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Device: ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone)
Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone
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Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew Tummon | 973-406-2872 | atummon@blackstonemedical.com |
United States, California | |
University of California Davis | Recruiting |
Sacramento, California, United States, 95816 | |
Contact: Martha Robinson 916-734-3660 martha.robinson@ucdmc.ucdavis.edu | |
United States, Colorado | |
Boulder Neurosurgical Associates | Recruiting |
Boulder, Colorado, United States, 80304 | |
Contact: Sigita Burneikiene, M.D. 303-938-5700 sigitab@bnasurg.com | |
United States, Florida | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33606 | |
Contact: Deborah Scott 813-259-0616 descott@hsc.usf.edu | |
United States, Louisiana | |
Spine Institute of Louisiana | Recruiting |
Shreveport, Louisiana, United States, 71101 | |
Contact: Ajay Jawahar, M.D. 318-629-5555 Ajawahar@louisianaspine.org | |
United States, Maryland | |
Brain and Spine Specialist | Recruiting |
Baltimore, Maryland, United States, 21215 | |
Contact: Alanvin Orpia 410-601-0960 aorpia@lifebridgehealth.org | |
United States, New Jersey | |
Cooper University Neurological Institute | Recruiting |
Camden, New Jersey, United States, 08103 | |
Contact: Christine Rickette 856-342-3024 Rickette-Chris@CooperHealth.edu | |
United States, New York | |
University of Rochester Medical Center | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Jacqueline Behr 585-273-2417 Jacqueline_Behr@URMC.Rochester.edu | |
United States, North Carolina | |
Triangle Orthopaedics Associates, P.A. | Recruiting |
Durham, North Carolina, United States, 27704 | |
Contact: Lynn V Kamm 919-220-5255 lkamm@triangleortho.com | |
United States, Pennsylvania | |
University of Pennsylvania, Department of Neurosurgery | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Marie Kerr 215-829-6720 kerrm@uphs.upenn.edu | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Bonnie Muntz-Pope 843-792-8967 muntzpob@musc.edu | |
United States, Tennessee | |
East Tennessee Brain and Spine Center | Recruiting |
Johnson City, Tennessee, United States, 37604 | |
Contact: Susan Maye 423-232-8301 susanmaye1@yahoo.com | |
United States, Texas | |
Texas Back Institute | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Dawn Delacy 972-403-5544 ddelacy@spinemarkcro.com | |
The San Antonio Orthopaedic Group | Not yet recruiting |
San Antonio, Texas, United States, 78216 | |
Contact: Veronica Reyes 210-396-5319 vreyes@tsaog.com |
Study Director: | Scott L Blumenthal, M.D. | Texas Back Institute |
Responsible Party: | Blackstone Medical Inc ( Andrew Tummon ) |
Study ID Numbers: | CP-01003 |
Study First Received: | March 10, 2008 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00637312 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |