NCT02108249|Completed
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Sponsor study identifier
observational
35
1 country
1
Study Start
April 2014
Actual (reported)Primary Completion
December 2019
Actual (reported)Study Completion
December 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2014
Actual (reported)April 2, 2014
Actual (reported)April 9, 2014
Actual (reported)December 2019
Actual (reported)December 2019
Actual (reported)% 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
% 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
Patients prospectively treated with Annex™ Adjacent Level System
Patients previously treated for adjacent level disease using other systems
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Carolinas Neurosurgery and Spine
Charlotte, North Carolina, 28204, United States
35 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2014
First Posted
April 9, 2014
Study Start
April 2014
Actual (reported)Primary Completion
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
Contact the study team to confirm eligibility.
December 2019
Actual (reported)Study Completion
December 2019
Actual (reported)Last Updated
October 22, 2020
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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