An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | September 2011 |
| Contact: | Brian Subach, MD |
| Phone: | 703-766-5404 |
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
