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

January 15, 2016 updated by: Alphatec Spine, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
    • Connecticut
      • Middleton, Connecticut, United States, 06457
    • North Carolina
      • Greensboro, North Carolina, United States, 27401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lumbar Degenerative Disc Disease
Biological: PureGen Osteoprogenitor Cell Allograft
PureGen Osteoprogenitor Cell Allograft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 24 months
Proportion of subjects with fusion at the 24 month visit
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alphatec Spine, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (ESTIMATE)

February 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-000058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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