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

• Sponsor: Alphatec Spine, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01293981
• Collaborator: (none)
• Enrollment: 6
• Locations: 3
• Patients Per Site: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Degenerative Disc Disease	Biological: PureGen Osteoprogenitor Cell Allograft

Study Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Lumbar Degenerative Disc Disease	Biological: PureGen Osteoprogenitor Cell Allograft; PureGen Osteoprogenitor Cell Allograft.

Outcome Measures

Primary Outcome Measures

1. Fusion [24 months]

   Proportion of subjects with fusion at the 24 month visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beverly Hills	California	United States
2		Middleton	Connecticut	United States	06457
3		Greensboro	North Carolina	United States	27401

Sponsors and Collaborators

• Alphatec Spine, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alphatec Spine, Inc.
• ClinicalTrials.gov Identifier: NCT01293981
• Other Study ID Numbers: PRO-000058
• First Posted: Feb 11, 2011
• Last Update Posted: Jan 20, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Intervertebral Disc Degeneration

Study Results

No Results Posted as of Jan 20, 2016