MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
| Status: | Recruiting | 
|---|---|
| Conditions: | Orthopedic | 
| Therapuetic Areas: | Orthopedics / Podiatry | 
| Healthy: | No | 
| Age Range: | 66 - Any | 
| Updated: | 4/4/2019 | 
| Start Date: | March 10, 2017 | 
| End Date: | December 2020 | 
| Contact: | Angie Lee | 
| Email: | alee@vertosmed.com | 
| Phone: | 877-958-6227 | 
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.
			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.
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).
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).
Inclusion Criteria:
- Medicare beneficiaries receiving MILD or interspinous process decompression
- Diagnosis of LSS with NC
- ≥66 years old
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
We found this trial at
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									75 Francis street
Boston, Massachusetts 02115
	
			Boston, Massachusetts 02115
(617) 732-5500 
							 
					Phone: 617-732-5500
					
		Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...  
  
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									330 Brookline Ave
Boston, Massachusetts 02215
	
			Boston, Massachusetts 02215
617-667-7000 
							 
					Phone: 317-667-7000
					
		Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...  
  
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									3550 Jerome Avenue
Bronx, New York 10467
	
			Bronx, New York 10467
(718) 920-4321 
							 
					Phone: 718-920-7246
					
		Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...  
  
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		Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...  
  
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									529 West Markham Street
Little Rock, Arkansas 72205
	
			Little Rock, Arkansas 72205
(501) 686-7000 
							 
					Phone: 501-686-7000
					
		University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...  
  
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									606 South Academy Street
Ahoskie, North Carolina 27910
	
			
					Ahoskie, North Carolina 27910
Phone: 252-209-3360
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									3535 Pentagon Boulevard
Beavercreek, Ohio 45431
	
			
					Beavercreek, Ohio 45431
Phone: 937-702-4000
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								Bradenton, Florida 34211			
	
			
					Phone: 941-792-1404
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									400 Court Street
Charleston, West Virginia 25301
	
			
					Charleston, West Virginia 25301
Phone: 304-347-6120
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								Chattanooga, Tennessee 37404			
	
			
					Phone: 423-698-6871
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									 5841 S Maryland Ave
Chicago, Illinois 60637
	
			Chicago, Illinois 60637
(773) 702-1000
							 
					Phone: 773-702-1000
					
		University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...  
  
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		The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...  
  
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									24420 Ford Road
Dearborn Heights, Michigan 48127
	
			
					Dearborn Heights, Michigan 48127
Phone: 313-202-9400
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									1111 6th Ave
Des Moines, Iowa 50314
	
			Des Moines, Iowa 50314
(515) 247-3121
							 
					Phone: 515-247-3121
					
		Mercy Medical Center - Des Moines Mercy Medical Center  
  
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