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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01357187
First received: May 18, 2011
Last updated: June 12, 2014
Last verified: June 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 12, 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 July 20, 2014