Lumbar Spinal Stenosis
Conditions
Keywords
Lumbar Spinal Stenosis, Interspinous process decompression, MILD, Medicare, Medicare Advantage
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.
Interventions
DEVICEMILD
MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Partial decompression is performed through the removal of tissue and bone at the symptomatic level confirmed with correlated MRI and clinical findings.
DEVICEInterspinous Process Decompression
Interspinous Process Decompression
Sponsors
Stryker Instruments
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants with harms associated with the index procedure | 24 months | 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. |
| Rate of surgical, minimally invasive intervention. | 24 months | Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure. |
Countries
United States
Contacts
CONTACTAngie Lee
CONTACTStephanie Guyon
Outcome results
None listed