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Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02108249
Recruitment Status : Unknown
Verified December 2014 by Spine Wave.
Recruitment status was:  Recruiting
First Posted : April 9, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Adjacent Level Disease Device: Annex™ Adjacent Level System

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Study Start Date : April 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Secondary Outcome Measures :
  1. % Pain reduction on VAS [ Time Frame: Up to 2 years post-treatment ]
  2. % Improvement in Disability using ODI [ Time Frame: Up to 2 years post-treatment ]
  3. % Improvement in Quality of Life using SF-36 [ Time Frame: Up to 2 years post-treatment ]
  4. % Patient Satisfaction with procedure [ Time Frame: Up to 2 years post-treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108249


Contacts
Contact: Lisa Bellincampi, Ph.D. 203-944-9494 lbellincampi@spinewave.com

Locations
United States, North Carolina
Carolinas Neurosurgery and Spine Recruiting
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Spine Wave
More Information

Responsible Party: Spine Wave
ClinicalTrials.gov Identifier: NCT02108249     History of Changes
Other Study ID Numbers: SW-ANX1401
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases