Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389597
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2006-10-18
Brief Title:
LDR Spine USA Mobi-CR Cervical Disc Prosthesis IDE
Sponsor:
LDR Spine USA
Organization:
LDR Spine USA
Study Overview
Official Title:
LDR Spine USA Mobi-CR Cervical Disc Prosthesis IDE
Status:
COMPLETED
Status Verified Date:
2017-11
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:
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nervespinal cord compression despite continued non-operative conservative treatment
Detailed Description:
Objectives of the Investigation
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nervespinal cord compression despite continued non-operative conservative treatment
Study Design Rationale
The study is a prospective randomized multi-center concurrently controlled investigation in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion ACDF in accordance with the Smith-Robinson procedure Patients will be followed for two years postsurgery primary endpoint and at 3 4 5 and 7 years thereafter
Duration of the Investigation
Patients will be followed post-operatively at 6 weeks and 3- 6- 12- 18- and 24-months After 24 months patients will continue to be followed at 34 5 and 7 years
Design Techniques to Avoid Bias
To eliminate selection bias investigational and control comparison groups will be assigned at random
Institutional Review Board
No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board IRB affiliated with the study center
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nervespinal cord compression despite continued non-operative conservative treatment
Study Design Rationale
The study is a prospective randomized multi-center concurrently controlled investigation in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion ACDF in accordance with the Smith-Robinson procedure Patients will be followed for two years postsurgery primary endpoint and at 3 4 5 and 7 years thereafter
Duration of the Investigation
Patients will be followed post-operatively at 6 weeks and 3- 6- 12- 18- and 24-months After 24 months patients will continue to be followed at 34 5 and 7 years
Design Techniques to Avoid Bias
To eliminate selection bias investigational and control comparison groups will be assigned at random
Institutional Review Board
No clinical studies will begin without documented approval of the clinical investigation by the Institutional Review Board IRB affiliated with the study center
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