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

Primary Purpose

Lumbar Degenerative Disc Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PureGen Osteoprogenitor Cell Allograft
Autograft bone
Sponsored by
Alphatec Spine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Degenerative Disc Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Graft Composite

Control Graft Composite

Arm Description

AlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique. Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator.

Contralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system. A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone The graft composite is placed on the randomized control side using standard technique for PLF

Outcomes

Primary Outcome Measures

Number of Patients With Fusion
Number of patients with fusion at the 6- and conditional 12- and 24-month visit

Secondary Outcome Measures

Full Information

First Posted
February 9, 2011
Last Updated
October 5, 2022
Sponsor
Alphatec Spine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01294007
Brief Title
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Product no longer on the market
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alphatec Spine, Inc.

4. Oversight

5. Study Description

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.
Detailed Description
This is a prospective, multi-center, observational, self-control study assessing screened and consented subjects undergoing instrumented posterolateral fusion for degenerative disc disease (DDD) at 1 to 2 contiguous levels between L1 and S1. Patients diagnosed with DDD will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo PLF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), and ZODIAC, Illico, or Xenon Fixation system (pedicle screw and rod fixation system) Subjects will be followed at 6 weeks, 3, 6, 12 and 24 month post-operative visits. Standard radiographs will be taken at these visits to evaluate fusion rate and quality. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) self-assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography (CT) scan will be taken at the 6-month to further assess rate and quality of fusion. A conditional 12 and 24 month post operative CT may also be taken. Procedure related and PureGen related adverse events will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Graft Composite
Arm Type
Experimental
Arm Description
AlphaGraft ProFuse Demineralized Bone Scaffold are soaked in PureGen according to Preparation for Use and handling technique. The graft composite is placed on the randomized study side contralateral to the autograft bone graft per surgeon's standard technique for PLF. The wound is closed according to surgeon's standard technique. Post operative care will be according to the site specific standard of care. An avoidance of heavy physical activity and limitations on working, lifting, bending etc. are common precautions post procedure. The decision to use a post operative orthosis is left to the discretion of the Investigator.
Arm Title
Control Graft Composite
Arm Type
Active Comparator
Arm Description
Contralateral to the study graft composite, placement of posterolateral fusion graft composite containing iliac crest bone (5 cc/level/side) and local autograft composite (equal volume split with study side). Supplemental posterior pedicle screw fixation utilizing Zodiac, Illico or Xenon Spinal Fixation system. A defined volume of iliac crest bone graft (indicated in table 2) is harvested and combined with 50% of the previously harvest morselized local bone The graft composite is placed on the randomized control side using standard technique for PLF
Intervention Type
Biological
Intervention Name(s)
PureGen Osteoprogenitor Cell Allograft
Intervention Description
PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.
Intervention Type
Procedure
Intervention Name(s)
Autograft bone
Intervention Description
Iliac Crest and Local Autograft Bone
Primary Outcome Measure Information:
Title
Number of Patients With Fusion
Description
Number of patients with fusion at the 6- and conditional 12- and 24-month visit
Time Frame
6, 12 and 24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
City
Beverly Hills
State/Province
California
Country
United States

12. IPD Sharing Statement

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

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