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Completed

NCT Number: NCT02093520

The MiDAS ENCORE Study

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

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Key information

Conditions

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Synovation Medical Group, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 65 years or older and a Medicare beneficiary.
  • Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
  • LSS with neurogenic claudication diagnosed via:
  • Symptomatic diagnosis and
  • Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum >2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
  • Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
  • Available to complete 6 month and one year follow-up visits.

Exclusion criteria

  • ODI Score < 31 (0-100 ODI Scale).
  • NPRS Score < 5 (0-10 NPRS Scale).
  • Prior surgery at any treatment level.
  • History of recent spinal fractures with current related pain symptoms.
  • Patients with Grade III or higher spondylolisthesis.
  • Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
  • Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
  • Patients previously randomized and/or treated in this clinical study.
  • Patients that have previously received the MILD procedure.
  • ESI during eight weeks prior to study enrollment.
  • Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
  • On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.

Treatment and study plan

MILD Procedure

Procedure

The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.

Other names: MILD lumbar decompression

Epidural steroid injection

Drug

Injection of epidural steroids into the lumbar spine

Other names: ESI

Primary outcomes

  1. Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months

    Time frame: 12 months

    Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.

Secondary outcomes

  1. Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months

    Time frame: 12 months

    Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.

  2. Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months

    Time frame: 12 months

    Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.

Sponsors and collaborators

Lead sponsor

Vertos Medical, Inc.

Industry

Registry information

Official study title

MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 21, 2014
Registry last updated
Dec 6, 2017

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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