Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-25 @ 4:19 PM
Study NCT ID:
NCT05101057
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
Sponsor:
Encore Medical, L.P.
Organization:
Study Overview
Official Title:
A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: