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TOPS™ System Post Marketing Study To Evaluate The Safety And Effectiveness Of TOPS™ System

Spinal Stenosis Clinical Trial

Official title:
A Study To Evaluate The Safety And Effectiveness Of TOPS™ System In The Lumbar Spine

Clinical Trial Summary

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.

Clinical Trial Description

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System. Patients who are scheduled to undergo spinal surgery as part of their medical treatment and comply with the study inclusion/exclusion criteria will be recruited. Patients will undergo standard surgical decompression prior to device implantation. For patients with two or three levels of disease, the TOPS System will be combined with the Versalink Fixation System. All study devices are CE marked. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01933607
Study type Interventional
Source Premia Spine
Contact Stephen McGillion, MD
Phone 02380796245
Email Stephen.McGillion@uhs.nhs.uk
Status Recruiting
Phase N/A
Start date May 2014
Completion date December 2016
View Details
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