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

V

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

lumbar decompression
Other group
Description:
Percutaneous lumbar decompression with mild® Device Kit.
Treatment:
Procedure: lumbar decompression

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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