Title

Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
  • Phase

    N/A
  • Study Type

    Observational
  • Status

    Terminated
  • Study Participants

    6
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.
Study Started
Feb 28
2011
Primary Completion
Jan 31
2012
Last Update
Jan 20
2016
Estimate

Biological PureGen Osteoprogenitor Cell Allograft

PureGen Osteoprogenitor Cell Allograft.

Lumbar Degenerative Disc Disease None

Population

Subjects diagnosed with symptomatic lumbar degenerative disc disease (DDD) at 1 or 2 contiguous levels between L1 and S1.

Criteria

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)
No Results Posted