NCT03072927 · Stryker Instruments
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
What this study is about
This forward-looking 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.
View original scientific description
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.
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 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.
Time frame: 24 months
Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Athens, Alabama
- Bay Minette, Alabama
- Birmingham, Alabama
- Decatur, Alabama
- Fairhope, Alabama
- Gardendale, Alabama
- Scottsboro, Alabama
- Tuscaloosa, Alabama
- Anchorage, Alaska
- Wasilla, Alaska
- Bullhead City, Arizona
- Chandler, Arizona
And 1271 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations