The MiDAS ENCORE Study

Study Overview
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Brief Summary
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Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.

Official Title
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MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication

Conditions
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Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Intervention / Treatment
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* Procedure: MILD Procedure
* Drug: Epidural Steroid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years or older and a Medicare beneficiary. 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. LSS with neurogenic claudication diagnosed via: Symptomatic diagnosis and 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. 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. Available to complete 6 month and one year follow-up visits. Exclusion Criteria: ODI Score < 31 (0-100 ODI Scale). NPRS Score < 5 (0-10 NPRS Scale). Prior surgery at any treatment level. History of recent spinal fractures with current related pain symptoms. Patients with Grade III or higher spondylolisthesis. 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.). 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. Patients previously randomized and/or treated in this clinical study. Patients that have previously received the MILD procedure. ESI during eight weeks prior to study enrollment. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MILD<br>The MILD procedure is an image-guided minimally-invasive lumbar decompression | Procedure: MILD Procedure<br>* 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.<br>* Other names: MILD lumbar decompression;|
| Active Comparator: Epidural Steroid Injection (ESI)<br>An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine. | Drug: Epidural Steroid Injection<br>* Injection of epidural steroids into the lumbar spine<br>* Other names: ESI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold. | 12 months | 
| Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication