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The objective of this study is to evaluate the clinical effectiveness of AmnioFixâ„¢ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other |
| |
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scheduled removal of posterior instrumentation with AmnioFix | Other |
| ||
| Scheduled removal of posterior instrumentation without AmnioFix |
| Measure | Description | Time Frame |
|---|---|---|
| Tenacity and frequency of soft tissue adhesion | At the time of removal of segmental posterior lumbar instrumentation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Subach, MD | Virginia Spine Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Spine Institute | Reston | Virginia | 20190 | United States |
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| Other |
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