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CompletedNCT01357187Updated Mar 17, 2015

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

An interventional study of Scheduled removal of posterior instrumentation with AmnioFix and Scheduled removal of posterior instrumentation without AmnioFix in Adhesions of Soft Tissue, sponsored by MiMedx Group, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by MiMedx Group, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adhesions of Soft Tissue

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Keywords

  • Lumbar pathology
  • requiring elective lumbar interbody fusion
03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's enrollment of 5 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

MiMedx Group, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Other
    Control

    Other: Scheduled removal of posterior instrumentation without AmnioFix

  • Experimental
    Treatment

    Other: Scheduled removal of posterior instrumentation with AmnioFix

Interventions

  • OtherScheduled removal of posterior instrumentation with AmnioFix
  • OtherScheduled removal of posterior instrumentation without AmnioFix
06

What researchers measure

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

07

Study locations

1 site
  • Virginia Spine Institute
    Reston, Virginia 20190, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01357187
Lead sponsor
MiMedx Group, Inc.
Responsible party
Sponsor
First posted
May 20, 2011
Start date
Sep 2011
Primary completion
May 2014
Completion
May 2014
Last update
Mar 17, 2015

Study contacts

Brian Subach, MD
principal investigator · Virginia Spine Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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