Vertos Mild - Post Market Patient Outcomes

NCT01076244 | Completed Results DMC

• 1 other identifier: #D1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Pain as Measured by Visual Analog Scale (VAS).

  A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.

  Baseline and six months

Secondary Outcomes (3)

• Improvement in Functional Mobility

  baseline and month 6

• Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).

  Baseline and month 6

• Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).

  Baseline and month 6

Study Arms (1)

Minimally invasive lumbar decompression

OTHER

Procedure: Minimally Invasive Lumbar Decompression

Interventions

Minimally Invasive Lumbar Decompression 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.

Minimally invasive lumbar decompression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Center for Pain Relief, Inc.: lead
• Vertos Medical, Inc.: collaborator

Study Sites (2)

The Center for Pain Relief, Inc.

Charleston, West Virginia, 25301, United States

Location

The Center for Pain Relief, Inc

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Timothy Deer
• Organization: Center for Pain Relief

Diana.tolentino@stfh.net

(304) 347-6144

Study Officials

• Timothy R Deer, MD

  Center for Pain Relief, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 2, 2013
• Results First Posted: April 2, 2013

Record last verified: 2013-02

Locations

US (2)