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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01357187
First received: May 18, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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: Open Label
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 ]

Estimated Enrollment: 50
Study Start Date: September 2011
Arms Assigned Interventions
Control Other: Scheduled removal of posterior instrumentation without AmnioFix
Experimental: Treatment Other: Scheduled removal of posterior instrumentation with AmnioFix

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01357187     History of Changes
Other Study ID Numbers: #11-06-02
Study First Received: May 18, 2011
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014