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

MiMedx

Status

Completed

Conditions

Adhesions of Soft Tissue

Treatments

Other: Scheduled removal of posterior instrumentation without AmnioFix

Other: Scheduled removal of posterior instrumentation with AmnioFix

Study type

Interventional

Funder types

Industry

Identifiers

NCT01357187

AFPIR001

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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