MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MILD, Interspinous Process Decompression.
- Who it may be relevant to
- Registry conditions: Lumbar Spinal Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device MILD
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. - Device Interspinous Process Decompression
Interspinous Process Decompression
Primary outcome measures
- Rate of participants with harms associated with the index procedure [Time frame: 24 months]
- Rate of surgical, minimally invasive intervention. [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2,343 centers
- Athens-Limestone Hospital — Athens
- North Baldwin Infirmary — Bay Minette
- Southside Pain Specialists — Birmingham
- St Vincents Birmingham — Birmingham
- The Univ of Alabama At Birmingham — Birmingham
- Birmingham Surgery Center — Birmingham
- Alabama Ortho Spine and Sports — Birmingham
- Outpatient Services East — Birmingham
- … and 2,335 more centers
Publications
- Staats PS, Hagedorn JM, Reece DE, Strand NH, Poree L. Percutaneous image-guided lumbar decompression and interspinous spacers for the treatment of lumbar spinal stenosis: A 2-year Medicare Claims Benchmark Study. Pain Pract. 2023 Sep;23(7):776-784. doi: 10.1111/papr.13256. Epub 2023 May 30. PMID 37254613
Identifiers
NCT: NCT03072927 · MILD Medicare Claims