Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415110
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-17
First Post:
2024-05-10
Brief Title:
A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
Sponsor:
Research Source
Organization:
Research Source
Study Overview
Official Title:
A Prospective Analysis of the Efficacy of Allosync Expand and Autograft Bone Graft in Open Lumbar Spinal Fusion
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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 purpose of this study is to assess the radiographic and clinical outcomes of spinal fusion following use of Allosync Expand and autograft bone graft
Detailed Description:
This is a single site prospective study with patients selected as study subjects from the Investigators standard patient population who fulfill the InclusionExclusion Criteria and agree to participate in the study The study surgery is standard of care with patients identified as requiring surgery prior to enrollment The study surgery is lumbar posterior fixation with supplemental posterolateral fusion at from 1 to 3 levels One side of the posterolateral fusion will be Allosync Expand utilizing the BMA Angel kit to hydrate and the other side to autograft bone control
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?:
False
Is an FDA AA801 Violation?:
None