Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

NCT ID: NCT00995371

Last Updated: 2013-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-05-31

Brief Summary

This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Conditions

Lumbar Spinal Stenosis

Keywords

Spinal Stenosis; Lumbar Spinal Stenosis; Laminotomy; Laminectomy; Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vertos mild® Minimally-Invasive Lumbar Decompression

Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.

Group Type: ACTIVE_COMPARATOR

MILD® (Minimally Invasive Lumbar Decompression)

Intervention Type: DEVICE

Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.

Epidural Steroid Injection

Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.

Group Type: ACTIVE_COMPARATOR

Epidural Steroid Injection

Intervention Type: DRUG

An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Interventions

MILD® (Minimally Invasive Lumbar Decompression)

Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.

Intervention Type: DEVICE

Epidural Steroid Injection

An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
• Prior failure of conservative therapy and ODI Score >20%.
• Radiologic evidence of LSS (L3-L5), Ligamentum flavum >2.5mm, confirmed by pre-op MRI and/or CT.
• Central canal cross sectional area ≤ 100 square mm.
• Anterior listhesis ≤ 5.0mm.
• Able to walk at least 10 feet unaided before being limited by pain.
• Available to complete 26 weeks of follow-up.
• A signed Informed Consent Form is obtained from the patient.
• Adults at least 18 years of age.

Exclusion Criteria

• Prior surgery at intended treatment level.
• History of recent spinal fractures with concurrent pain symptoms.
• Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)
• Significant / symptomatic disc protrusion or osteophyte formation.
• Excessive / symptomatic facet hypertrophy.
• Bleeding disorders and/or current use of anti-coagulants.
• Use of ASA and/or NSAID within 5 days of treatment.
• Pregnant and/or breastfeeding.
• Epidural steroids previously administered (not ESI naive)
• Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
• Dementia and/or inability to give informed consent.
• Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).
• On Workman's Compensation or considering litigation associated with back pain.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertos Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Coastal Orthopedics & Sports Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lora Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Coastal Orthopedics & Sports Medicine

Locations

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, United States

Countries

United States

References

Brown LL. A double-blind, randomized, prospective study of epidural steroid injection vs. the mild(R) procedure in patients with symptomatic lumbar spinal stenosis. Pain Pract. 2012 Jun;12(5):333-41. doi: 10.1111/j.1533-2500.2011.00518.x. Epub 2012 Jan 25.

Reference Type: DERIVED

PMID: 22272730 (View on PubMed)

Other Identifiers

VMD001LB

Identifier Type: -

Identifier Source: org_study_id