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

Conditions

• Lumbar Spinal Stenosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MILD — DEVICE
  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 — DEVICE
  Interspinous Process Decompression

Study Details

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 Dates

Start date

Mar 10, 2017

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

8,000 participants (estimated)

Arms

• Arm: MILD
  All Medicare patients treated with MILD as reported via CPT® Code 0275T or successor codes (62330/62331).
• Arm: Interspinous Process Decompression
  All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.

Primary Outcome Measure

Rate of participants with harms associated with the index procedure [ Time Frame: 24 months ]

Central Contacts

• Angie Lee
  877-958-6227
  [email protected]
• Stephanie Guyon
  [email protected]

Locations (2306)