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

Completed · Not applicable

Conditions studied: Adhesions of Soft Tissue

In brief

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.

Key facts

Study ID

NCT01357187

Run by

MiMedx Group, Inc.

People needed

5

Starts

2011-09-01

Expected to finish

2014-05-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Virginia Spine Institute — Reston, Virginia, United States

Full record on ClinicalTrials.gov

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