Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease (NeoDisc™)
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|ClinicalTrials.gov Identifier: NCT00478088|
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : June 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cervical Disc Degenerative Disorder||Device: NeoDisc Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||March 2012|
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
Active Comparator: 2
Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
- Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status [ Time Frame: August 2010 ]
- ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24 [ Time Frame: August 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478088
|Principal Investigator:||Scott Kitchel, MD||Medical Monitor|