NCT02234154

Post-market Study of the TOPS™ System

A Study to Evaluate the Safety and Effectiveness of the TOPS System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Premia Spine · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lumbar Spinal Stenosis
• Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	TOPS System	Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2014-09-09
• Last updated: 2016-04-18

Locations

1 site across 1 country: United Kingdom