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

Alphatec Spine

Status: Terminated

Conditions: Lumbar Degenerative Disc Disease

Treatments: Biological: PureGen Osteoprogenitor Cell Allograft

Study type: Observational

Funder types: Industry

Identifiers

NCT01293981

PRO-000058

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

6 participants in 1 patient group

Lumbar Degenerative Disc Disease

Treatment:

Biological: PureGen Osteoprogenitor Cell Allograft