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 |
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.
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).
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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