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

Recruiting now

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT03072927

Run by

Stryker Instruments

People needed

8000

Starts

2017-03-10

Expected to finish

2026-12-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medicare beneficiaries receiving MILD or interspinous process decompression
• Diagnosis of LSS with NC

You may not qualify if…

• 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 is running

• North Baldwin Infirmary — Bay Minette, Alabama, United States (enrolling)
• Southside Pain Specialists — Birmingham, Alabama, United States (enrolling)
• St Vincents Birmingham — Birmingham, Alabama, United States (enrolling)
• The Univ of Alabama At Birmingham — Birmingham, Alabama, United States (enrolling)
• Birmingham Surgery Center — Birmingham, Alabama, United States (enrolling)
• Alabama Ortho Spine and Sports — Birmingham, Alabama, United States (enrolling)
• Outpatient Services East — Birmingham, Alabama, United States (enrolling)
• St Vincents One Nineteen Health and — Birmingham, Alabama, United States (enrolling)
• Decatur Ambulatory Surgery Center — Decatur, Alabama, United States (enrolling)
• Baldwin County Surg Ctr — Fairhope, Alabama, United States (enrolling)
• Gardendale Surgical Center — Gardendale, Alabama, United States (enrolling)
• Highland Medical Center — Scottsboro, Alabama, United States (enrolling)
• Tuscaloosa Surgery Center — Tuscaloosa, Alabama, United States (enrolling)
• AA Spine & Pain Clinic — Anchorage, Alaska, United States (enrolling)
• Copper Basin Surg Ctr — Wasilla, Alaska, United States (enrolling)
• Bullhead City Community Hosp — Bullhead City, Arizona, United States (enrolling)
• Arizona Specialty Surgery Center — Chandler, Arizona, United States (enrolling)
• Chandler Surgical Ctr PLC — Chandler, Arizona, United States (enrolling)
• Advanced Pain Modalities — Chandler, Arizona, United States (enrolling)
• Northern Arizona Surgicenter — Flagstaff, Arizona, United States (enrolling)
• Surgery Center at Flagstaff Bone and Joint — Flagstaff, Arizona, United States (enrolling)
• Mountain View Surgery Center of Gilbert — Gilbert, Arizona, United States (enrolling)
• Phoenix Spine and Joint — Gilbert, Arizona, United States (enrolling)
• Premier Endoscopy Surgery Center — Gilbert, Arizona, United States (enrolling)
• Athens-Limestone Hospital — Athens, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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