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

Lumbar Degenerative Disc Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01294007
• Other study ID #: PRO-000061
• Status: Terminated
• Phase: N/A
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2022
• Source: Alphatec Spine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

Biological:
• PureGen Osteoprogenitor Cell Allograft
PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.

Procedure:
• Autograft bone
Iliac Crest and Local Autograft Bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alphatec Spine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Fusion	Number of patients with fusion at the 6- and conditional 12- and 24-month visit	6, 12 and 24 month