NCT01076244

Vertos Mild - Post Market Patient Outcomes

Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The Center for Pain Relief, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.

Detailed description

Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Minimally Invasive Lumbar Decompression	This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-02-26
• Last updated: 2013-04-02
• Results posted: 2013-04-02

Locations

2 sites across 1 country: United States