Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696470
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-10-18
Brief Title:
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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 purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM This will be a non-inferiority study looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages
Detailed Description:
This is a prospective single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled Patients will be implanted with DePuy Conduit Titanium ACDF cage DePuy Synthes Raynham MA A retrospective comparision group will be used The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft
This single-centered study will enroll up to 58 subjects with subjects followed for 24 months post-surgery All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries The inclusionexclusion criteria are listed below
This single-centered study will enroll up to 58 subjects with subjects followed for 24 months post-surgery All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries The inclusionexclusion criteria are listed below
Study Oversight
Has Oversight DMC:
None
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?:
None