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

NCT01293981 | Terminated

• 1 other identifier: PRO-000058
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Fusion

  Proportion of subjects with fusion at the 24 month visit

  24 months

Study Arms (1)

Lumbar Degenerative Disc Disease

Biological: PureGen Osteoprogenitor Cell Allograft

Interventions

PureGen Osteoprogenitor Cell Allograft BIOLOGICAL

PureGen Osteoprogenitor Cell Allograft.

Lumbar Degenerative Disc Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (3)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Middleton, Connecticut, 06457, United States

Location

Unknown Facility

Greensboro, North Carolina, 27401, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (3)