Ignite Creation Date:
2024-05-06 @ 7:13 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02492724
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2015-07-06
Brief Title:
Activ C European Multicenter Study
Sponsor:
Aesculap AG
Organization:
Aesculap AG
Study Overview
Official Title:
Activ C Disc Prosthesis European Multi-Center Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2015-07
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:
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease A maximum of 200 cases will be enrolled into the study An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject Thus it is anticipated that the study will require a minimum of 55 years Patients will be assessed preoperatively intraoperatively prior to discharge and again at 6 weeks 6 months 1 year 2 years and 4 years postoperatively from the date of surgery
Detailed Description:
The activ C Disc Prosthesis pursues the goal of restoring the disc function the geometry and motion of the cervical disc Its concept is based on a ball and socket joint anchored between adjacent vertebral bodies The modular prosthesis comprises the following elements an inferior CoCr plate component anchored in the endplate of the caudal vertebral body The UHMWPE inlay is securely fixed in this inferior component The second element is the superior CoCr component which is anchored in the end plate of the cranial vertebral body It forms a ball joint with the inlay of the inferior plate component
The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means spikes and grooves on the superior end plate a small keel on the inferior end plate whereas secondary stability is facilitated by an osseointegrative Plasmapore coating
The objective of the study is to collect outcome information on the Activ C Disc Prosthesis
The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means spikes and grooves on the superior end plate a small keel on the inferior end plate whereas secondary stability is facilitated by an osseointegrative Plasmapore coating
The objective of the study is to collect outcome information on the Activ C Disc Prosthesis
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