Back to resultsAn Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
Primary Purpose
Adhesions of Soft Tissue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scheduled removal of posterior instrumentation with AmnioFix
Scheduled removal of posterior instrumentation without AmnioFix
Sponsored by
About this trial
This is an interventional treatment trial for Adhesions of Soft Tissue focused on measuring Lumbar pathology, requiring elective lumbar interbody fusion
Eligibility 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
Sites / Locations
- Virginia Spine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Tenacity and frequency of soft tissue adhesion
Secondary Outcome Measures
Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site
Number of intra-operative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01357187
Brief Title
An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
Official Title
An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesions of Soft Tissue
Keywords
Lumbar pathology, requiring elective lumbar interbody fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Scheduled removal of posterior instrumentation with AmnioFix
Intervention Type
Other
Intervention Name(s)
Scheduled removal of posterior instrumentation without AmnioFix
Primary Outcome Measure Information:
Title
Tenacity and frequency of soft tissue adhesion
Time Frame
At the time of removal of segmental posterior lumbar instrumentation
Secondary Outcome Measure Information:
Title
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
Title
Number of intra-operative complications
Time Frame
At the time of removal of segmental posterior lumbar instrumentation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Subach, MD
Organizational Affiliation
Virginia Spine Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Spine Institute
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
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