The MiDAS ENCORE Study

Spinal Stenosis, Lumbar Region, With Neurogenic Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093520
• Other study ID #: MiDAS ENCORE
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: October 31, 2017
• Start date: May 2014
• Est. completion date: October 2017

Study information

• Verified date: May 2017
• Source: Vertos Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: October 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. 65 years or older and a Medicare beneficiary.

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:

1. ODI Score < 31 (0-100 ODI Scale).

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intermittent Claudication
• Spinal Stenosis
• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Intervention

Procedure:
• 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.

Drug:
• Epidural Steroid Injection
Injection of epidural steroids into the lumbar spine

Locations

Country	Name	City	State
United States	Millennium Pain Center	Bloomington	Illinois
United States	MI Interventional Pain Center	Brownstown Charter Township	Michigan
United States	Synovation Medical Group	Chula Vista	California
United States	Frankfort Pain Clinic	Frankfort	Kentucky
United States	Spine Intervention Medical Group/Fresno Surgical Hospital	Fresno	California
United States	Southern Spine Institute	Mount Pleasant	South Carolina
United States	The Spine Institute	Murrieta	California
United States	SC Spine and Pain Specialists	Myrtle Beach	South Carolina
United States	Newport Beach Headache and Pain	Newport Beach	California
United States	Mayo Clinic Pain Management	Rochester	Minnesota
United States	Premier Pain	Shrewsbury	New Jersey
United States	Michigan Pain Specialist	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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