Vertos Mild - Post Market Patient Outcomes

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT01076244

Run by

The Center for Pain Relief, Inc.

People needed

46

Starts

2010-02-01

Expected to finish

2012-01-01

Last updated by the study team

2013-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• The Center for Pain Relief, Inc. — Charleston, West Virginia, United States
• The Center for Pain Relief, Inc — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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