An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
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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.
Condition or disease
Adhesions of Soft Tissue
Other: Scheduled removal of posterior instrumentation with AmnioFixOther: Scheduled removal of posterior instrumentation without AmnioFix
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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)
Failure to sign or understand informed consent information