Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01609374
Status:
UNKNOWN
Last Update Posted:
2019-09-18
First Post:
2012-05-24
Brief Title:
Restore CLINICAL TRIAL
Sponsor:
Spinal Kinetics
Organization:
Spinal Kinetics
Study Overview
Official Title:
Prospective Non-Randomized Concurrently Controlled Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion ACDF for the Treatment of Symptomatic Cervical Radiculopathy
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
This is a prospective concurrently controlled multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion ACDF for the treatment of symptomatic cervical radiculopathy with or without cord compression Some participating sites will enroll just M6-C patients while others will enroll just ACDF patients
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention confirmed clinically and radiographically at one vertebral level from C3 to C7
A total of 243 subjects will be included at up to 20 sites
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention confirmed clinically and radiographically at one vertebral level from C3 to C7
A total of 243 subjects will be included at up to 20 sites
Detailed Description:
None
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