Post-market Study of the TOPS™ System

Not Applicable

• Conditions: Lumbar Spinal Stenosis; Spondylolisthesis

• Registration Number: NCT02234154
• Lead Sponsor: Premia Spine

Brief 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.

Detailed Description

This study is being conducted to evaluate the TOPS™ SP System from ("TOPS™ System" or "TOPS"). TOPS is an alternative to spinal fusion and is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis (abnormal/excessive movement of the vertebrae causing pain in the lower back and legs) and spinal stenosis (narrowing of the spinal canal resulting in compression of nerves producing symptoms of pain, numbness and tingling in the legs).

Study Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Study Start: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in ODI and Improvement in VAS leg score v	24 months post implantation	Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success.

Secondary Outcome Measures

Name	Time	Method
Improvement in ZCQ scores	24 months postoperatively	A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
Improvement in back and leg visual analog scales (VAS)	24 month postoperatively	A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
Quality of life (SF-36)	24 months postoperatively	A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
Maintenance or improvement in neurological symptoms	24 months postoperatively	A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.

Trial Locations

Locations (1)

Queens Medical Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom