Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

Completed

• Conditions: Degenerative Disc Disease; Adjacent Level Disease
• Interventions: Device: Annex™ Adjacent Level System

• Registration Number: NCT02108249
• Lead Sponsor: Spine Wave

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Annex Group	Annex™ Adjacent Level System	Patients prospectively treated with Annex™ Adjacent Level System

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Carolinas Neurosurgery and Spine; 🇺🇸 Charlotte, North Carolina, United States