Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462729
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
LDGraft in Single Level Anterior Lumbar Interbody Fusion ALIF
Sponsor:
Locate Bio Pty Ltd
Organization:
Locate Bio Ltd
Study Overview
Official Title:
A Randomized Study of LDGraft in Single Level Anterior Lumbar Interbody Fusion ALIF
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RESTORE
Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of LDGraft investigational device compared to 100 human tissue product allograft bone control when applied in an ALIF procedure in the treatment of patients with lumbar degenerative disc disease DDD
Detailed Description:
This is a prospective randomized controlled single-blind dose-finding multi-center study which intends to demonstrate the safety of both LDGraft groups versus allograft during a single level ALIF procedure This is a first in human FIH study
The study will enroll patients with lumbar degenerative disc disease DDD requiring single level ALIF The procedure will involve use of an intervertebral cage and fixation plate and screws
Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 332 to the LDGraft groups investigational or the allograft control group Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion
The study will enroll patients with lumbar degenerative disc disease DDD requiring single level ALIF The procedure will involve use of an intervertebral cage and fixation plate and screws
Upon successful completion of the Screening period and confirmation of eligibility the participant will allocated 332 to the LDGraft groups investigational or the allograft control group Participants will be blinded to the treatment assigned however the surgical procedure and the post operative recovery will be managed in accordance with standard clinical practice for anterior lumbar interbody fusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None