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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:66 - Any
Updated:4/4/2019
Start Date:March 10, 2017
End Date:December 2020
Contact:Angie Lee
Email:alee@vertosmed.com
Phone:877-958-6227

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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.

Using the Centers for Medicare and Medicaid (CMS) Medicare Research Identifiable Files (RIFs)
containing all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare
fee-for-service program, claims-based patient history and demographics will be combined with
longitudinal analyses. In this study, the control group will include all patients receiving
interspinous process decompression (IPD) for the treatment of lumbar spinal stenosis (LSS)
with neurogenic claudication (NC). The treatment group will include all patients receiving
MILD during the enrollment period. The date of the MILD and IPD procedure will serve as the
index procedure date for 24-month follow-up. This study is exempt from IRB oversight
(Department of Health and Human Services regulations 45 CFR 46).

Inclusion Criteria:

- Medicare beneficiaries receiving MILD or interspinous process decompression

- Diagnosis of LSS with NC

- ≥66 years old

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
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San Francisco, California 94115
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75 Francis street
Boston, Massachusetts 02115
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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3550 Jerome Avenue
Bronx, New York 10467
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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529 West Markham Street
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606 South Academy Street
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1111 6th Ave
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