Clinical trial NCT01129921: Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
Official title: Comparative Study of Sham Versus Mild® (Minimally Invasive Lumbar Decompression) Procedure in Patients Diagnosed With Symptomatic Moderate to Severe Lumbar Central Canal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Stenosis Central Canal
Keywords: Lumbar Spine Stenosis
Decompression
Lead sponsor: Napa Pain Institute
Sponsor class: OTHER
Collaborators: name: Vertos Medical, Inc.
First posted: 2010-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal stenosis. Sham patients were eligible to choose to cross-over and have the actual decompression procedure after week 6 exam.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of recent spinal fractures with concurrent pain symptoms as determined by the Investigator.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Disk 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 (NSAID) within five days of treatment.
* Epidural steroid administration within prior 3 weeks(of procedure or sham)
* Inability of the subject to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
* Metabolic wound healing pathologies deemed by Investigator to compromise study outcome.
* Dementia and/or inability to give informed consent.
* Pregnancy and/or breastfeeding.
* On Workman's Compensation or considering litigation associated with back pain.

Primary outcomes:
measure: Visual Analog Scale (VAS) <=4
timeFrame: Week 6 to 12 prior to cross-over
measure: Visual Analog Scale (VAS) <=4
timeFrame: Week 6 to 12 & Year One After Sham to mild x-over
measure: Visual Analog Scale (VAS) Mean Improvement
timeFrame: Baseline and Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Napa
country: United States
facility: Napa Pain Institute
state: California
Study officials:
affiliation: Napa Pain Institute
name: Eric Grigsby, MD
role: PRINCIPAL_INVESTIGATOR
References: