MiDAS I (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: Interlaminar Decompression

Study type

Interventional

Funder types

Industry

Identifiers

NCT00956631

MiDAS I

Details and patient eligibility

About

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Enrollment

78 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.
Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI and/or CT.
Central canal cross sectional area ≤ 100 square mm.
Anterior listhesis ≤ 5.0mm.
Able to walk at least 10 feet unaided before being limited by pain.
Available to complete 12 weeks of follow-up.
Consistent with the intended labeling statement for use.
Able to use all package components to perform the procedure.
A signed Informed Consent Form is obtained from the patient.

Exclusion criteria

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Significant / symptomatic disk protrusion or osteophyte formation.
Excessive / symptomatic facet hypertrophy.
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 within prior three weeks.
Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
Dementia and/or inability to give informed consent.
Pregnancy.
Intended treatment that is defined by the product labeling contraindications.
On Workman's Compensation or considering litigation associated with back pain.