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Sponsored by: |
NuVasive |
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Information provided by: | NuVasive |
ClinicalTrials.gov Identifier: | NCT00478088 |
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
Condition | Intervention |
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One Level Degenerative Disc Disease |
Device: NeoDisc |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease |
Estimated Enrollment: | 488 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
NeoDisc
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Device: NeoDisc
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
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2: Active Comparator
ACDF
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Device: NeoDisc
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
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The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. Implantation of the device will result in artificial replacement of a pathologically damaged or surgically removed cervical disc. Use of the device also obviates the need to harvest bone graft from the patient's iliac crest, a common and painful part of current surgical techniques.
The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc height, with functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Spondylosis is defined as MRI or CT-confirmed disc dessication, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25% less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining.
Exclusion Criteria:
Responsible Party: | NuVasive ( Mary Shippey/Clinical Affairs Manager ) |
Study ID Numbers: | NUVA-ND-0501 |
Study First Received: | May 22, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00478088 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Single Level Cervical Disc Disease |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |