Comparing MILD procedure outcomes for lumbar spinal stenosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the incidence rates of surgical and minimally invasive interventions among Medicare beneficiaries who have undergone the MILD procedure for lumbar spinal stenosis. It will track outcomes and potential harms associated with the MILD procedure over a 24-month period, using Medicare claims data. The study will include a treatment group of patients receiving MILD and a control group of patients undergoing interspinous process decompression, allowing for a comprehensive analysis of both approaches. Enrollment will continue until the sponsor decides to stop the study.

Why it matters

Who can join: the full rules

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 it's running

• Athens-Limestone Hospital
  Athens, Alabama, United States Recruiting
• North Baldwin Infirmary
  Bay Minette, Alabama, United States Recruiting
• Southside Pain Specialists
  Birmingham, Alabama, United States Recruiting
• St Vincents Birmingham
  Birmingham, Alabama, United States Recruiting
• The Univ of Alabama At Birmingham
  Birmingham, Alabama, United States Recruiting
• Birmingham Surgery Center
  Birmingham, Alabama, United States Recruiting

+2344 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Angie Lee
• Email: angie.lee@stryker.com
• Phone: 877-958-6227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.