Vertos Mild - Post Market Patient Outcomes

NCT ID: NCT01076244

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally invasive lumbar decompression

Group Type: OTHER

Minimally Invasive Lumbar Decompression

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
• Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
• Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
• Central canal cross sectional area clearly reduced per MRI/CT report
• If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
• Able to walk at least 10 feet unaided before being limited by pain
• Available to complete 26 weeks of follow up
• A signed Consent Form is obtained from the patient
• Adults 18 years of age or older

Exclusion Criteria

• Prior surgery at the intended treatment level
• Compound fracture with intraspinal retropulsion contributing to spinal stenosis
• Disabling back or leg pain from causes other than lumbar spinal stenosis
• Disc protrusion or osteophyte formation severe enough to confound study outcome
• Facet hypertrophy severe enough to confound study outcome
• Bleeding disorders and/or current use of anti-coagulants
• Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
• Epidural steroids with 3 weeks prior to procedure
• Inability of patient to lie prone for any reason with anesthesia support
• Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
• Dementia and/or inability to give informed consent
• Pregnant and/or breastfeeding
• On workman's Compensation or considering litigation associated with back pain

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

The Center for Pain Relief, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy R Deer, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Pain Relief, Inc

Locations

The Center for Pain Relief, Inc.

Charleston, West Virginia, United States

The Center for Pain Relief, Inc

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

#D1

Identifier Type: -

Identifier Source: org_study_id

NCT01130350

Identifier Type: -

Identifier Source: nct_alias