Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072927
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

Tracking Information
First Submitted Date February 18, 2017
First Posted Date March 7, 2017
Last Update Posted Date August 3, 2021
Actual Study Start Date March 10, 2017
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Official Title MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
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.
Detailed Description In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46).
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 fee-for-service or Medicare Advantage for one year prior to their index procedure and two years post index procedure.
Condition Lumbar Spinal Stenosis
Intervention 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.
Study Groups/Cohorts
  • MILD
    All Medicare patients treated with MILD as reported via CPT® Code 0275T (or successor code(s)).
    Intervention: Device: MILD
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2017)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angie Lee 877-958-6227 alee@vertosmed.com
Contact: Karen L Davis kdavis@vertosmed.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03072927
Other Study ID Numbers MILD Medicare Claims
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Vertos Medical, Inc.
Study Sponsor Vertos Medical, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Vertos Medical, Inc.
Verification Date July 2021