MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
ConditionLumbar Spinal Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStryker Instruments
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Medicare beneficiaries receiving MILD or interspinous process decompression
Diagnosis of LSS with NC
Disqualifiers
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
Trial population
Study participants will include Medicare beneficiaries for whom claims have been submitted to the Medicare Claims database and who have been enrolled in Medicare fee-for-service or Medicare Advantage for one year prior to their index procedure and two years post index procedure.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
MILD
DeviceMILD 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
DeviceInterspinous Process Decompression
Treatment groups
8,000 Participants
are divided into 2 treatment groupsGroup A: MILD1 intervention
Group B: Interspinous Process Decompression1 intervention
Trial outcomes
Primary outcomes
1
Rate of participants with harms associated with the index procedure
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.
Time frame
24 months2
Rate of surgical, minimally invasive intervention.
Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov