Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)

Terminated

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Biological: PureGen Osteoprogenitor Cell Allograft

• Registration Number: NCT01293981
• Lead Sponsor: Alphatec Spine, Inc.

Brief Summary

The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
• Unresponsive to conservative treatment for at least 6 months
• Radiographic confirmation of primary diagnosis

Exclusion Criteria

• More than 2 levels requiring lumbar interbody fusion
• Spondylolisthesis greater than Grade I
• Prior failed fusion surgery at any lumbar level(s)
• Local or systemic infection past or present
• Active systemic disease
• Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
• BMI greater than 40
• Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
• Use of post operative Spinal Cord Stimulator (SCS)
• Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
• Known or suspected history of alcohol and/or drug abuse
• Involved in pending litigation or worker's compensation related to the spine
• Pregnant or plans to become pregnant during the course of the study
• Insulin-dependent diabetes mellitus
• Known sensitivity to device materials
• Life expectancy less than duration of study
• Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
• Undergoing chemotherapy or radiation treatment
• Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar Degenerative Disc Disease	PureGen Osteoprogenitor Cell Allograft	-

Primary Outcome Measures

Name	Time	Method
Fusion	24 months	Proportion of subjects with fusion at the 24 month visit