Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215306
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-09-13
Brief Title:
CHARITÉ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
Sponsor:
DePuy Spine
Organization:
DePuy Spine
Study Overview
Official Title:
Clinical Investigation of the SB Charite III Intervertebral Disc Spacer
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
Brief Summary:
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine either L4L5 or L5S1
Detailed Description:
Treatments for disc degeneration have historically included conservative modalities such as rest heat electrotherapy physical therapy and analgesics to surgery Currently there are two main surgical techniques for treatment of disc degeneration 1 nucleotomy or diskectomy ie excision of part or all of the degenerated disc which is typically performed for treatment of radicular syndrome in the case of disc herniation and 2 spinal fusion ie grafting bone between the vertebrae adjacent to the degenerated disc to eliminate articulation at the damaged segment which is typically performed for treatment of degeneration together with instability and reduction of the intervertebral space Rigid internal fixation may also be used to promote fusion
The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of degenerative disc disease as an alternative to spinal fusion to preserve function in the lumbar vertebral region Each institution participating in the study was to treat the first 5 consecutive study participants with the CHARITE to as it involves a modification to the technique used for anterior fusion Data will be collected on these training cases but will not be included in the comparison with the control fusion treatment
Comparison Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared to outcomes for patients treated with anterior lumbar interbody fusion
The CHARITÉ Artificial Disc is designed to provide a new therapeutic option for treatment of degenerative disc disease as an alternative to spinal fusion to preserve function in the lumbar vertebral region Each institution participating in the study was to treat the first 5 consecutive study participants with the CHARITE to as it involves a modification to the technique used for anterior fusion Data will be collected on these training cases but will not be included in the comparison with the control fusion treatment
Comparison Outcomes for patients treated with the CHARITÉ Artificial Disc will be compared to outcomes for patients treated with anterior lumbar interbody fusion
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