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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adhesions of Soft Tissue

Intervention / Treatment
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* Other: Scheduled removal of posterior instrumentation with AmnioFix
* Other: Scheduled removal of posterior instrumentation without AmnioFix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br> | Other: Scheduled removal of posterior instrumentation without AmnioFix<br> <br> |
| Experimental: Treatment<br> | Other: Scheduled removal of posterior instrumentation with AmnioFix<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tenacity and frequency of soft tissue adhesion |  | At the time of removal of segmental posterior lumbar instrumentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site |  | At the time of removal of segmental posterior lumbar instrumentation | 
| Number of intra-operative complications |  | At the time of removal of segmental posterior lumbar instrumentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar pathology, requiring elective lumbar interbody fusion