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

C

Coastal Orthopedics & Sports Medicine

Status and phase

Completed
Phase 4

Conditions

Lumbar Spinal Stenosis

Treatments

Drug: Epidural Steroid Injection
Device: MILD® (Minimally Invasive Lumbar Decompression)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00995371
VMD001LB

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

38 participants in 2 patient groups

Vertos mild® Minimally-Invasive Lumbar Decompression
Active Comparator group
Description:
Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
Treatment:
Device: MILD® (Minimally Invasive Lumbar Decompression)
Epidural Steroid Injection
Active Comparator group
Description:
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.
Treatment:
Drug: Epidural Steroid Injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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