MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
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
- Lumbar Spinal Stenosis
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
Arm | Description | Assigned Intervention |
---|---|---|
MILD | All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)). |
|
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. |
|
Recruiting Locations
Houston, Texas 77030
(713) 799-9990
Houston, Texas 77030
713-799-9990
Houston, Texas 77024
713-461-3547
Houston, Texas 77043
(713) 337-1111
Houston, Texas 77043
713-337-1111
Houston, Texas 77008
(713) 343-1080
Houston, Texas 77090
(281) 440-5797
Katy, Texas 77450
281-492-1234
Angleton, Texas 77515
(979) 848-5900
Sugar Land, Texas 77479
(281) 243-1000
More Details
- Status
- Recruiting
- Sponsor
- Vertos Medical, Inc.
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.