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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Device: MILD


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MILD<br>All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)). | Device: MILD<br>* 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.<br>|
| Interspinous Process Decompression<br>All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with harms associated with the index procedure | Rate of participants with harms associated with the index procedure including, but not limited to, revisions, displacement, mechanical complications, and death. Complications will be counted if they are recorded during the index hospitalization, or any rehospitalization within 30 days of discharge. | 24 months | 
| Rate of surgical, minimally invasive intervention. | Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Spinal Stenosis, Interspinous process decompression, MILD, Medicare, Medicare Advantage