MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

Description

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Conditions

Lumbar Spinal Stenosis

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Study Overview

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Study Details

Study overview

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

Condition
Lumbar Spinal Stenosis
Intervention / Treatment

-

Contacts and Locations

Athens

Athens-Limestone Hospital, Athens, Alabama, United States, 35611

Birmingham

Southside Pain Specialists, Birmingham, Alabama, United States, 35205

Birmingham

St Vincents Birmingham, Birmingham, Alabama, United States, 35205

Birmingham

Birmingham Surgery Center, Birmingham, Alabama, United States, 35233

Birmingham

Outpatient Services East, Birmingham, Alabama, United States, 35235

Decatur

Decatur Ambulatory Surgery Center, Decatur, Alabama, United States, 35603

Gardendale

Gardendale Surgical Center, Gardendale, Alabama, United States, 35070

Scottsboro

Highland Medical Center, Scottsboro, Alabama, United States, 35768

Tuscaloosa

Tuscaloosa Surgery Center, Tuscaloosa, Alabama, United States, 35406

Anchorage

AA Spine & Pain Clinic, Anchorage, Alaska, United States, 99508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Medicare beneficiaries receiving MILD or interspinous process decompression
  • * Diagnosis of LSS with NC
  • * Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vertos Medical, Inc.,

Study Record Dates

2026-12