An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal

An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal

The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.

Inclusion Criteria:

• Adults (18 years or older)
• Diagnosed with lumbar pathology requiring elective lumbar interbody fusion
• Willingness to comply to follow-up examinations and diagnostic imaging procedures
• Ability to give full written informed consent

Exclusion Criteria:

• Previous surgical procedure performed at same site
• Sign or symptoms of other disease which could result in allograft failure
• Require a corpectomy
• Participating in another drug or device clinical trial
• Pregnant or may become pregnant during the study
• Prisoner
• Involved in workmen's compensation or other litigation relative to a spine injury
• Past medical history of allograft implantation which resulted in graft failure
• Any condition requiring treatment above the normal standard of care
• Currently taking medications which could affect graft incorporation (supervising physicians discretion)
• Auto-Immune disease
• Renal failure
• Failure to sign or understand informed consent information
• History of drug and/or alcohol abuse
• Allergic to aminoglycosides