Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
NCT ID: NCT02108249
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2014-04-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Annex Group
Patients prospectively treated with Annex™ Adjacent Level System
Annex™ Adjacent Level System
Retrospective Control
Patients previously treated for adjacent level disease using other systems
No interventions assigned to this group
Interventions
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Annex™ Adjacent Level System
Eligibility Criteria
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Inclusion Criteria
* Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).
Exclusion Criteria
* cervical fusion candidates
* extraspinal cause of back pain
* local or systemic infection
* pregnant / able to become pregnant and not following a reliable contraceptive method
* Severe osteoporosis or osteopenia
* Morbid obesity defined as BMI \> 40
* Anatomy or other factors that prohibit safe surgical access to the surgical site
* Allergy or sensitivity to any component of the treatment procedure
* Inadequate tissue coverage over the operative site
* Inadequate bone stock or bone quality
* Fever or leukocytosis
* Uncorrectable coagulopathy or hemorrhagic diathesis
* Cardiopulmonary conditions that present prohibitive anesthesia risk
* Neuromuscular disease or disorder
* Mental illness
* Has an active workman's compensation claim
18 Years
85 Years
ALL
No
Sponsors
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Spine Wave
INDUSTRY
Responsible Party
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Locations
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Carolinas Neurosurgery and Spine
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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SW-ANX1401
Identifier Type: -
Identifier Source: org_study_id
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