Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

October 21, 2020 updated by: Spine Wave
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Neurosurgery and Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subject population for both the treatment and control groups will include adult (skeletally mature) men and women who were previously implanted with rigid posterior fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed adjacent level disease (ALD) at a lumbar level.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Annex Group
Patients prospectively treated with Annex™ Adjacent Level System
Device: Annex™ Adjacent Level System
Retrospective Control
Patients previously treated for adjacent level disease using other systems

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spine Wave

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW-ANX1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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