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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.
ClinicalTrials.gov Identifier:
NCT01293981
First received: February 9, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Lumbar Degenerative Disc Disease
 Biological: PureGen Osteoprogenitor Cell Allograft

Study Type: Observational
Study Design: 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

Further study details as provided by Alphatec Spine, Inc.:

Primary Outcome Measures:
  • Fusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of subjects with fusion at the 24 month visit


Estimated Enrollment: 150
Study Start Date: February 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumbar Degenerative Disc Disease Biological: PureGen Osteoprogenitor Cell Allograft
PureGen Osteoprogenitor Cell Allograft.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293981

Locations
United States, California
Beverly Hills, California, United States
United States, Connecticut
Middleton, Connecticut, United States, 06457
United States, North Carolina
Greensboro, North Carolina, United States, 27401
Sponsors and Collaborators
Alphatec Spine, Inc.
  More Information

No publications provided

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01293981     History of Changes
Other Study ID Numbers: PRO-000058
Study First Received: February 9, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013