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

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01293981
• Other study ID #: PRO-000058
• Status: Terminated
• Phase: N/A
• First received: February 9, 2011
• Last updated: January 15, 2016
• Start date: February 2011

Study information

• Verified date: January 2016
• Source: Alphatec Spine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

Biological:
• PureGen Osteoprogenitor Cell Allograft
PureGen Osteoprogenitor Cell Allograft.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alphatec Spine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	Proportion of subjects with fusion at the 24 month visit	24 months	No