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

V

Vertos Medical

Status

Completed

Conditions

Lumbar Spinal Stenosis

Treatments

Procedure: Percutaneous Lumbar Decompression
Drug: Epidural Steroid Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01315145
MiDAS III

Details and patient eligibility

About

This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

Full description

The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.

Enrollment

138 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Lumbar spinal stenosis (LSS) with neurogenic claudication where the Visual Analog Scale (VAS) of back and leg pain average is ≥ 5.
  • Prior failure of conservative therapy.
  • Oswestry Disability Index (ODI) score of ≥ 31%.
  • Radiologic evidence of LSS, with unilateral or bilateral ligamentum flavum ≥ 4.1mm confirmed by pre-op MRI performed within 6-12 months of baseline visit.
  • Able to walk ≥ 10 feet before being limited by pain.
  • Available to complete 24-months of follow-up.
  • Adults ≥ 50 years of age.

Exclusion criteria

  • Prior surgery at intended treatment level.
  • History of spinal fractures with current related pain symptoms.
  • Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, vascular claudication symptoms, etc.).
  • Significant/symptomatic disc protrusion or osteophyte formation judged by the Investigator as possible confounding factor to study results.
  • Excessive facet hypertrophy judged by the Investigator as possible confounding factor to study results.
  • Significant symptomatic foraminal stenosis.
  • Confirmed anterior or retro-listhesis ≥ 3mm.
  • Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure.
  • Able to walk ≥ 200 yards unaided in erect non-flexed position before being limited by pain.
  • Able to stand ≥ 15 minutes in erect, non-flexed position before being limited by pain.
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment.
  • Pregnant and/or breastfeeding.
  • Body mass index (BMI) ≥ 32 as calculated using the patient's weight multiplied by 703 then divided by height in inches squared.
  • Epidural steroid, systemic steroid or any spine interventional procedure within prior six weeks of study procedure.
  • Dementia and/or inability to give informed consent and to understand and complete follow-up patient reported outcomes forms.
  • Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
  • On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
  • Unable to tolerate MRI (pacemaker, spinal cord stimulator, etc.).
  • Intrathecal pump.
  • Any medical condition determined by the Investigator that would not allow subject to fulfill trial requirements or safely tolerate procedures in this study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

138 participants in 2 patient groups

Percutaneous Lumbar Decompression
Active Comparator group
Description:
Patients receiving percutaneous decompression using the mild® Device Kit.
Treatment:
Procedure: Percutaneous Lumbar Decompression
Lumbar Epidural Steroid Injection
Active Comparator group
Description:
Injection of epidural steroids into the lumbar spine
Treatment:
Drug: Epidural Steroid Injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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