Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Ce… (NCT01129921) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
United States40 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pul…
What they're measuring
1
Visual Analog Scale (VAS) <=4
Timeframe: Week 6 to 12 prior to cross-over
2
Visual Analog Scale (VAS) <=4
Timeframe: Week 6 to 12 & Year One After Sham to mild x-over