Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04982835
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2019-09-17
Brief Title:
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Sponsor:
Spinal Kinetics
Organization:
Orthofix Inc
Study Overview
Official Title:
M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
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 contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression
Detailed Description:
Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group Patients should have failed at least six weeks of conservative treatment or demonstrate progressive symptoms despite continued non-operative treatment For the study 263 patients will undergo either a two-level cervical artificial disc procedure or an instrumented ACDF procedure as per site group assignment Patients will be evaluated clinically radiographically and via the collection of patient-reported outcomes at 6 Weeks 3 Months 6 Months 12 Months and 24 Months The primary endpoint is Overall Success at 24 Months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None