Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2014-05-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MILD
The MILD procedure is an image-guided minimally-invasive lumbar decompression
MILD Procedure
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Epidural Steroid Injection (ESI)
An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Interventions
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MILD Procedure
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
3. LSS with neurogenic claudication diagnosed via:
1. Symptomatic diagnosis and
2. Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum \>2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
4. Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
5. Available to complete 6 month and one year follow-up visits.
Exclusion Criteria
2. NPRS Score \< 5 (0-10 NPRS Scale).
3. Prior surgery at any treatment level.
4. History of recent spinal fractures with current related pain symptoms.
5. Patients with Grade III or higher spondylolisthesis.
6. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
7. Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
8. Patients previously randomized and/or treated in this clinical study.
9. Patients that have previously received the MILD procedure.
10. ESI during eight weeks prior to study enrollment.
11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
65 Years
ALL
No
Sponsors
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Vertos Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ramsin Benyamin, MD
Role: PRINCIPAL_INVESTIGATOR
AAPM; ASIPP; ISIS; ASA
Peter Staats, MD
Role: PRINCIPAL_INVESTIGATOR
AAPM; ASIPP; ASA
Locations
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Synovation Medical Group
Chula Vista, California, United States
Spine Intervention Medical Group/Fresno Surgical Hospital
Fresno, California, United States
The Spine Institute
Murrieta, California, United States
Newport Beach Headache and Pain
Newport Beach, California, United States
Millennium Pain Center
Bloomington, Illinois, United States
Frankfort Pain Clinic
Frankfort, Kentucky, United States
MI Interventional Pain Center
Cherry Island, Michigan, United States
Michigan Pain Specialist
Ypsilanti, Michigan, United States
Mayo Clinic Pain Management
Rochester, Minnesota, United States
Premier Pain
Shrewsbury, New Jersey, United States
Southern Spine Institute
Mt. Pleasant, South Carolina, United States
SC Spine and Pain Specialists
Myrtle Beach, South Carolina, United States
Countries
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References
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Staats PS, Chafin TB, Golovac S, Kim CK, Li S, Richardson WB, Vallejo R, Wahezi SE, Washabaugh EP 3rd, Benyamin RM; MiDAS ENCORE Investigators. Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE. Reg Anesth Pain Med. 2018 Oct;43(7):789-794. doi: 10.1097/AAP.0000000000000868.
Benyamin RM, Staats PS, MiDAS Encore I. MILD(R) Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016 May;19(4):229-42.
Staats PS, Benyamin RM; MiDAS ENCORE Investigators. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results. Pain Physician. 2016 Feb;19(2):25-38.
Other Identifiers
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MiDAS ENCORE
Identifier Type: -
Identifier Source: org_study_id