Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 3:52 AM
Study NCT ID:
NCT01291134
Status:
TERMINATED
Last Update Posted:
2022-03-03
First Post:
2011-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PureGen: Radiographic Analysis of Fusion for ACDF
Sponsor:
Alphatec Spine, Inc.
Organization:
Study Overview
Official Title:
PureGen Osteoprogenitor Cell Allograft: A Radiographic Analysis of Rate and Quality of Fusion in Patients Undergoing Anterior Cervical Discectomy and Fusion (ACDF)
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Product is no longer on the market
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 study is to evaluate the rate and quality of spinal fusion utilizing PureGen Osteoprogenitor Cell Allograft in Anterior Cervical Discectomy and Fusion (ACDF).
Detailed Description:
This is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (DDD)
Patients diagnosed with cervical degenerative disc disease will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).
Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.
Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.
Patients diagnosed with cervical degenerative disc disease will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo ACDF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), a radiolucent cervical interbody spacer, and Trestle or Reveal Anterior Cervical Plating System (plate and screw fixation system).
Subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. Standard radiographs will be taken at these visits to assess fusion rate and quality. SF-12, NDI and VAS self assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. A conditional 12-month post operative CT may also be taken. Procedure related and device related adverse events will be monitored throughout the study.
Outcome data will be compared to published and/or retrospective data for the standard of care for DDD patients undergoing ACDF.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: