Other Clinical Trial - PureGen: Radiographic Analysis of Fusion for ACDF

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cervical Degenerative Disc Disease
Intervertebral Disc Degeneration

Clinical Trial Details

NCT number	NCT01291134
Study type	Observational
Source	Alphatec Spine, Inc.
Contact
Status	Terminated
Phase
Start date	February 2011
Completion date	August 2013

View Details

See also
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