NCT01294007

Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

A Radiographic Analysis Using PureGen Osteoprogenitor Cell Allograft Versus Autologous Bone in Posterolateral Fusion in a Side-by-Side Comparison in the Same Patient (PLF)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Alphatec Spine, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.

Detailed description

This is a prospective, multi-center, observational, self-control study assessing screened and consented subjects undergoing instrumented posterolateral fusion for degenerative disc disease (DDD) at 1 to 2 contiguous levels between L1 and S1. Patients diagnosed with DDD 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 PLF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), and ZODIAC, Illico, or Xenon Fixation system (pedicle screw and rod fixation system) Subjects will be followed at 6 weeks, 3, 6, 12 and 24 month post-operative visits. Standard radiographs will be taken at these visits to evaluate fusion rate and quality. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) self-assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography (CT) scan will be taken at the 6-month to further assess rate and quality of fusion. A conditional 12 and 24 month post operative CT may also be taken. Procedure related and PureGen related adverse events will be monitored throughout the study.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
BIOLOGICAL	PureGen Osteoprogenitor Cell Allograft	PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.
PROCEDURE	Autograft bone	Iliac Crest and Local Autograft Bone

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-02-11
• Last updated: 2022-11-02
• Results posted: 2022-10-05

Locations

1 site across 1 country: United States