Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

Spine Wave

Status

Completed

Conditions

Degenerative Disc Disease

Adjacent Level Disease

Treatments

Device: Annex™ Adjacent Level System

Study type

Observational

Funder types

Industry

Identifiers

NCT02108249

SW-ANX1401

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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