This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 47 for:    annex
Previous Study | Return to List | Next Study

Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Spine Wave.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Spine Wave
ClinicalTrials.gov Identifier:
NCT02108249
First received: April 2, 2014
Last updated: December 8, 2014
Last verified: December 2014
  Purpose
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 Intervention
Degenerative Disc Disease Adjacent Level Disease Device: Annex™ Adjacent Level System

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:


Further study details as provided by Spine Wave:

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

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

Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 2, 2014
Last Updated: December 8, 2014

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

ClinicalTrials.gov processed this record on July 21, 2017