Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000319
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-21
First Post:
2023-07-25
Brief Title:
Natural Matrix Protein NMP Fibers in Cervical and Lumbar Interbody Fusion
Sponsor:
Induce Biologics USA Inc
Organization:
Induce Biologics USA Inc
Study Overview
Official Title:
Prospective Evaluation of Natural Matrix Protein NMP Fibers in Cervical and Lumbar Interbody Fusion
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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 aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein NMP fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease DDD spinal stenosis spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels
Detailed Description:
The study involves a retrospective review of patients medical records and prospective collection of X-rays and patient outcome questionnaires
The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria
There will be 4 prospective study visits following consent Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery
The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria
There will be 4 prospective study visits following consent Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery
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?:
None
Is an FDA AA801 Violation?:
None