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Trial record 1 of 1 for:    NCT03072927
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MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

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ClinicalTrials.gov Identifier: NCT03072927
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Device: MILD

Detailed Description:
Using the Centers for Medicare and Medicaid (CMS) Medicare Research Identifiable Files (RIFs) containing all medical claims for 100% of Medicare beneficiaries enrolled in the Medicare fee-for-service program, claims-based patient history and demographics will be combined with longitudinal analyses. In this study, the control group will include all patients receiving interspinous process decompression (IPD) for the treatment of lumbar spinal stenosis (LSS) with neurogenic claudication (NC). The treatment group will include all patients receiving MILD during the enrollment period. The date of the MILD and IPD procedure will serve as the index procedure date for 24-month follow-up. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46).
Study Design
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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Other
Official Title: MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

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Groups and Cohorts
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Group/Cohort Intervention/treatment
MILD
All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).
 Device: MILD
MILD is performed under fluoroscopic image guidance through an ipsilateral interlaminar dorsal approach to the spine. Following epidurography, 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
All Medicare patients treated with interspinous process decompression (CPT Code 22869 or 22870, or successor code(s)) for the treatment of LSS with NC.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of surgical, minimally invasive intervention. [ Time Frame: 24 months ]
    Measure the rate of Medicare beneficiary surgical and minimally invasive intervention for LSS with NC post index procedure.

  2. Rate of participants with harms associated with the index procedure [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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 FFS for one year prior to their index procedure and two years post index procedure.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072927


Contacts
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Contact: Angie Lee 877-958-6227 alee@vertosmed.com
Contact: Karen L Davis kdavis@vertosmed.com

Locations
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Sponsors and Collaborators
Vertos Medical, Inc.
More Information
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Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT03072927    
Other Study ID Numbers: MILD Medicare Claims
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vertos Medical, Inc.:
Lumbar Spinal Stenosis
Interspinous process decompression
MILD
Medicare
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases