Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310440
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2006-04-03
Brief Title:
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Sponsor:
CeraPedics Inc
Organization:
CeraPedics Inc
Study Overview
Official Title:
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
Status:
COMPLETED
Status Verified Date:
2020-03
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 trial is to evaluate if P-15 bone putty investigational device is not inferior in effectiveness and safety to local autologous bone control device when applied in instrumented anterior cervical discectomy and fusion ACDF with use of a structural allograft ring in patients with degenerative cervical disc disease
Detailed Description:
Anterior Cervical Discectomy and Fusion ACDF is a common surgical treatment option for symptomatic degenerative cervical disk disease in patients who fail conservative treatment i-FACTOR bone graft is a unique anorganic bone mineral ABM and small peptide P-15 P-15 is a synthetic fifteen amino acid polypeptide that mimics the cell-binding domain of Type I human collagen and is responsible for osteogenic cell attachment via alpha2-beta1 integrins
This is randomized controlled multi-center prospective FDA IDE study conducted to assess the safety and effectiveness of i-FACTOR bone graft Cerapedics Inc Westminster CO in patients treated with single level ACDF Patients received i-FACTOR bone graft or local autologous bone inside a structural allograft
This is randomized controlled multi-center prospective FDA IDE study conducted to assess the safety and effectiveness of i-FACTOR bone graft Cerapedics Inc Westminster CO in patients treated with single level ACDF Patients received i-FACTOR bone graft or local autologous bone inside a structural allograft
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