Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478088
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2007-05-22
Brief Title:
Evaluating The Safety and Effectiveness of The NeoDisc Versus ACDF in Subjects With Single-Level Cervical Disc Disease
Sponsor:
NuVasive
Organization:
NuVasive
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoDisc
Brief Summary:
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 revisionreoperationremoval rate 3 complication rate and 4 maintenance or improvement in neurologic status
Detailed Description:
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 patients 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 andor loss of disc height with functional neurological deficit ie 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
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 andor loss of disc height with functional neurological deficit ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None