MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Vertos Medical

Status and phase

Completed

Phase 4

Conditions

Lumbar Spinal Stenosis

Treatments

Procedure: lumbar decompression

Study type

Interventional

Funder types

Industry

Identifiers

NCT01082159

MiDAS II

Details and patient eligibility

About

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.
Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.
Central canal cross sectional area clearly reduced per MRI/CT report.
If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.
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 patient.
Adults at least 18 years of age.

Exclusion criteria

Prior surgery at intended treatment level.
Compound fracture with interspinal retropulsion contributing to spinal stenosis.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
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 steroid administration within prior three weeks (of procedure).
Inability of the patient 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 outcomes.
Dementia and/or inability to give informed consent.
Pregnant and/or breastfeeding.
On Workman's Compensation or considering litigation associated with back pain.