Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258499
Status:
WITHDRAWN
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Bone Healing Accelerant BHA Versus Autologous Bone Grafting ABG for Hindfoot or Ankle Arthrodesis
Sponsor:
Carmell Therapeutics Corporation
Organization:
Carmell Therapeutics Corporation
Study Overview
Official Title:
A Multicenter Randomized Controlled Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study never started and is on hold until further notice
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant BHA product when applied to the joint space of the ankle of hindfoot the section of the foot immediately below the ankle joint during fusion surgery It is hypothesized that by 6 months the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None