Clinical trial NCT01076244: Vertos Mild - Post Market Patient Outcomes
Official title: Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: The Center for Pain Relief, Inc.
Sponsor class: OTHER
Collaborators: name: Vertos Medical, Inc.
First posted: 2010-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain as Measured by Visual Analog Scale (VAS).
timeFrame: Baseline and six months
Secondary outcomes:
measure: Improvement in Functional Mobility
timeFrame: baseline and month 6
measure: Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
timeFrame: Baseline and month 6
measure: Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
timeFrame: Baseline and month 6
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Center for Pain Relief, Inc.
state: West Virginia
city: Charleston
country: United States
facility: The Center for Pain Relief, Inc
state: West Virginia
Study officials:
affiliation: Center for Pain Relief, Inc
name: Timothy R Deer, MD
role: PRINCIPAL_INVESTIGATOR
References: