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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.
ClinicalTrials.gov Identifier:
NCT01294007
First received: February 9, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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 Intervention
Lumbar Degenerative Disc Disease
Biological: PureGen Osteoprogenitor Cell Allograft
Procedure: Autograft bone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

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

Primary Outcome Measures:
  • Fusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of subjects with fusion at the 6- and conditional 12- and 24-month visit


Estimated Enrollment: 50
Study Start Date: February 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294007

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

No publications provided

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT01294007     History of Changes
Other Study ID Numbers: PRO-000061
Study First Received: February 9, 2011
Last Updated: December 31, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014