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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357187
First Posted: May 20, 2011
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MiMedx Group, Inc.
  Purpose
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 Intervention
Adhesions of Soft Tissue Other: Scheduled removal of posterior instrumentation with AmnioFix Other: Scheduled removal of posterior instrumentation without AmnioFix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Tenacity and frequency of soft tissue adhesion [ Time Frame: At the time of removal of segmental posterior lumbar instrumentation ]

Secondary Outcome Measures:
  • Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site [ Time Frame: At the time of removal of segmental posterior lumbar instrumentation ]
  • Number of intra-operative complications [ Time Frame: At the time of removal of segmental posterior lumbar instrumentation ]

Enrollment: 5
Study Start Date: September 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Other: Scheduled removal of posterior instrumentation without AmnioFix
Experimental: Treatment Other: Scheduled removal of posterior instrumentation with AmnioFix

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357187


Locations
United States, Virginia
Virginia Spine Institute
Reston, Virginia, United States, 20190
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: Brian Subach, MD Virginia Spine Institute
  More Information

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01357187     History of Changes
Other Study ID Numbers: AFPIR001
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: March 17, 2015
Last Verified: June 2014

Keywords provided by MiMedx Group, Inc.:
Lumbar pathology
requiring elective lumbar interbody fusion

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes