Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT03162666
Status:
WITHDRAWN
Last Update Posted:
2021-08-23
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Outcomes Using an Expandable Spacer
Sponsor:
Globus Medical Inc
Organization:
Study Overview
Official Title:
Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The participating party (Rush) stopped the study because of logistic issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
Detailed Description:
The evaluation is based on the following elements.
1. Safety as measured by the rate of serious operative and post-operative complications.
2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
3. Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
1. Safety as measured by the rate of serious operative and post-operative complications.
2. Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
3. Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: