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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Medicare beneficiaries receiving MILD or interspinous process decompression - Diagnosis of LSS with NC

Exclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
MILD All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).
  • Device: MILD
    MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Following epidurography, partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
Interspinous Process Decompression All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.
  • Device: Interspinous Process Decompression
    Interspinous Process Decompression

Recruiting Locations

MedStar Good Samaritan Hospital
Baltimore, Maryland 21239
Contact:
443-444-8000

MedStar Franklin Square Medical Center
Baltimore, Maryland 21237
Contact:
443-777-7000

Medstar Montgomery Medical Center
Olney, Maryland 20832
Contact:
301-774-8882

Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
202-444-7599

MedStar St. Mary's Hospital
Leonardtown, Maryland 20650
Contact:
301-475-8981

MedStar Franklin Square Medical Center
Rosedale, Maryland 21237
Contact:
443-777-7000

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
202-877-7000

MedStar Health Harbor Hospital
Baltimore, Maryland 21225
Contact:
410-350-3200

MedStar Harbor Hospital
Baltimore, Maryland 21225
Contact:
410-350-3200

MedStar Union Memorial Hospital
Baltimore, Maryland 21218
Contact:
410-554-2000

MedStar Union Memorial Hospital
Baltimore, Maryland 21218
Contact:
410-544-2000

MedStar Southern Maryland Hospital Center
Clinton, Maryland 20735
Contact:
301-868-8000

Howard County Medical Center
Saint Paul, Nebraska 68873
Contact:
308-754-4421

MedStar Health at Lafayette Center
Washington, District of Columbia 20036

More Details

Status
Recruiting
Sponsor
Vertos Medical, Inc.

Study Contact

Angie Lee
877-958-6227
alee@vertosmed.com

Detailed Description

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.