Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

Completed

Conditions studied: Degenerative Disc Disease, Adjacent Level Disease

In brief

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.

Key facts

Study ID

NCT02108249

Run by

Spine Wave

People needed

35

Starts

2014-04-01

Expected to finish

2019-12-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women 18-85 years of age
• Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).

You may not qualify if…

• 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

Where it is running

• Carolinas Neurosurgery and Spine — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.