Annex™ Adjacent Level System for Treatment of Adjacent Level Disease



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 85
Updated:4/2/2016
Start Date:April 2014
Contact:Lisa Bellincampi, Ph.D.
Email:lbellincampi@spinewave.com
Phone:203-944-9494

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Trial Summary
Trial Overview
Inclusion Criteria

The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes
of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the
lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be
used with commercially available pedicle screw fixation systems in order to extend existing
pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to
historical control.


Inclusion Criteria:

- Men or women 18-85 years of age

- Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).

Exclusion Criteria:

- trauma, tumor, pseudoarthrosis, revision, or same-level recurrent stenosis

- 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
We found this trial at
1
site
Carolinas Neurosurgery and Spine
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
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