Vertos Mild - Post Market Patient Outcomes

The Center for Pain Relief, Inc.

Status

Completed

Conditions

Lumbar Spinal Stenosis

Treatments

Procedure: Minimally Invasive Lumbar Decompression

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01076244

#D1

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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