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Completed

NCT Number: NCT02108249

Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

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.

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Key information

Conditions

Degenerative Disc Disease Adjacent Level Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Neurosurgery and Spine

Charlotte, North Carolina, 28204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Annex™ Adjacent Level System

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Spine Wave

Industry

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2014
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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