Ignite Creation Date:
2024-05-05 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00583375
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2007-12-20
Brief Title:
Augment Bone Graft Formerly GEM OS1 Bone Graft Compared to Autologous Bone Graft in Foot and Ankle Fusions
Sponsor:
BioMimetic Therapeutics
Organization:
BioMimetic Therapeutics
Study Overview
Official Title:
A Prospective Randomized Controlled Multi-Center Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Status:
COMPLETED
Status Verified Date:
2018-03
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:
STUDY OBJECTIVES Demonstrate equivalent clinical and radiologic outcomes to the gold standard ABG in a representative clinical model hindfoot and ankle fusions
STUDY HYPOTHESIS Augment Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis
STUDY RATIONALE Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE Investigational Device Exemption IDE for Premarket Approval PMA Application as a bone regeneration system pivotal phase
STUDY HYPOTHESIS Augment Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis
STUDY RATIONALE Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE Investigational Device Exemption IDE for Premarket Approval PMA Application as a bone regeneration system pivotal phase
Detailed Description:
None
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