Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02108249

Enrollment

Registered

2014-04-09

Start date

2014-04-30

Completion date

2019-12-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjacent Level Disease, Degenerative Disc Disease

Brief summary

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.

Interventions

DEVICEAnnex™ Adjacent Level System

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
% Improvement in Operative/Discharge parameters including surgical time and hospital stay	within 30 days after treatment
Surgical Complication rate compared to retrospective chart review	Within 30 days of treatment

Secondary

Measure	Time frame
% Pain reduction on VAS	Up to 2 years post-treatment
% Improvement in Disability using ODI	Up to 2 years post-treatment
% Improvement in Quality of Life using SF-36	Up to 2 years post-treatment
% Patient Satisfaction with procedure	Up to 2 years post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026