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OpenTrials
Completed

NCT Number: NCT01357187

An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft 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.

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Key information

Conditions

Adhesions of Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Spine Institute

Reston, Virginia, 20190, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scheduled removal of posterior instrumentation with AmnioFix

Other

Scheduled removal of posterior instrumentation without AmnioFix

Other

Primary outcomes

  1. Tenacity and frequency of soft tissue adhesion

    Time frame: At the time of removal of segmental posterior lumbar instrumentation

Secondary outcomes

  1. 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

  2. Number of intra-operative complications

    Time frame: At the time of removal of segmental posterior lumbar instrumentation

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study title

An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 20, 2011
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.