Annex™ Adjacent Level System for Treatment of Adjacent Level Disease

NCT02108249 | Completed

• 1 other identifier: SW-ANX1401
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Adjacent Level Disease

Outcome Measures

Primary Outcomes (2)

• % Improvement in Operative/Discharge parameters including surgical time and hospital stay

  within 30 days after treatment

• Surgical Complication rate compared to retrospective chart review

  Within 30 days of treatment

Secondary Outcomes (4)

• % Pain reduction on VAS

  Up to 2 years post-treatment

• % Improvement in Disability using ODI

  Up to 2 years post-treatment

• % Improvement in Quality of Life using SF-36

  Up to 2 years post-treatment

• % Patient Satisfaction with procedure

  Up to 2 years post-treatment

Study Arms (2)

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

Interventions

Annex™ Adjacent Level System DEVICE

Annex Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men or women 18-85 years of age
• Single level adjacent level segment disease (ALD) in the lumbar spine (L1-S1).

You may not qualify if:

• 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

Sponsors & Collaborators

• Spine Wave: lead

Study Sites (1)

Carolinas Neurosurgery and Spine

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

US (1)