Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294007
Recruitment Status : Terminated (Product no longer on the market)
First Posted : February 11, 2011
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Alphatec Spine, Inc.

Brief Summary:
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Biological: PureGen Osteoprogenitor Cell Allograft Procedure: Autograft bone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Radiographic Analysis Using PureGen Osteoprogenitor Cell Allograft Versus Autologous Bone in Posterolateral Fusion in a Side-by-Side Comparison in the Same Patient (PLF)
Study Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Study Graft Composite Biological: PureGen Osteoprogenitor Cell Allograft
PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.
Active Comparator: Control Graft Composite Procedure: Autograft bone
Iliac Crest and Local Autograft Bone

Primary Outcome Measures :
  1. Fusion [ Time Frame: 6 months ]
    Proportion of subjects with fusion at the 6- and conditional 12- and 24-month visit

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1
  • Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF)
  • Unresponsive to conservative treatment for at least 6 months
  • Radiographic evidence of primary diagnosis

Exclusion Criteria:

  • More than 2 levels requiring posterolateral fusion
  • Spondylolisthesis greater than Grade I
  • Prior failed fusion surgery at any lumbar level(s)
  • Systemic or local infection in the disc or cervical spine, past or present
  • Active systemic disease
  • Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
  • Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
  • BMI greater than 40
  • Use of post operative Spinal Cord Stimulator (SCS)
  • Known or suspected history of alcohol and/or drug abuse
  • Involved in pending litigation or worker's compensation related to the spine
  • Pregnant or planning to become pregnant during the course of the study
  • Insulin-dependent diabetes mellitus
  • 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, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs.
  • Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01294007

United States, California
Beverly Hills, California, United States
Sponsors and Collaborators
Alphatec Spine, Inc.

Responsible Party: Alphatec Spine, Inc. Identifier: NCT01294007     History of Changes
Other Study ID Numbers: PRO-000061
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

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