Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

Degenerative Disc Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108249
• Other study ID #: SW-ANX1401
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Spine Wave
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjacent Level Disease
• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Annex™ Adjacent Level System

Locations

Country	Name	City	State
United States	Carolinas Neurosurgery and Spine	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Spine Wave

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Improvement in Operative/Discharge parameters including surgical time and hospital stay		within 30 days after treatment
Primary	Surgical Complication rate compared to retrospective chart review		Within 30 days of treatment
Secondary	% Pain reduction on VAS		Up to 2 years post-treatment
Secondary	% Improvement in Disability using ODI		Up to 2 years post-treatment
Secondary	% Improvement in Quality of Life using SF-36		Up to 2 years post-treatment
Secondary	% Patient Satisfaction with procedure		Up to 2 years post-treatment