An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
NCT ID: NCT01357187
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2011-09-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Scheduled removal of posterior instrumentation without AmnioFix
Treatment
Scheduled removal of posterior instrumentation with AmnioFix
Interventions
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Scheduled removal of posterior instrumentation with AmnioFix
Scheduled removal of posterior instrumentation without AmnioFix
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Subach, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Spine Institute
Locations
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Virginia Spine Institute
Reston, Virginia, United States
Countries
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Other Identifiers
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AFPIR001
Identifier Type: -
Identifier Source: org_study_id
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