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Completed

NCT Number: NCT01082159

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

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.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Space Coast Pain Institute, Merritt Island, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lumbar decompression

Procedure

The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Other names: The mild® Device Kit

Primary outcomes

  1. Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).

    Time frame: Baseline and Month 6

    The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.

    The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.

  2. Function as Measured Subjectively by the Oswestry Disability Index Questionnaire

    Time frame: Baseline and Month 6

    Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.

  3. Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).

    Time frame: Baseline and Month 6

    The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.

Sponsors and collaborators

Lead sponsor

Vertos Medical, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Mar 8, 2010
Registry last updated
Apr 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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