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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Interspinous Process Decompression: Interspinous Process Decompression

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (2388)

+ 2348 more sites — see the full list on the official registry below.

More Stryker Instruments trials in the USA

Other trials for the same condition