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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00995371
Other study ID # VMD001LB
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2009
Last updated September 13, 2013
Start date August 2009
Est. completion date May 2013

Study information

Verified date September 2013
Source Coastal Orthopedics & Sports Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
MILD® (Minimally Invasive Lumbar Decompression)
Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.
Drug:
Epidural Steroid Injection
An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Locations

Country Name City State
United States Coastal Orthopedics & Sports Medicine Bradenton Florida

Sponsors (2)

Lead Sponsor Collaborator
Coastal Orthopedics & Sports Medicine Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in VAS Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value. Baseline and 6 weeks prior to cross-over No
Primary Mean Change in ODI Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.
The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value
Baseline and 6 weeks prior to cross-over No
Primary Mean Change in VAS Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value. Baseline and 26 weeks After ESI to mild cross-over No
Primary Mean Change in ODI Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life.
The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value
Baseline and 26 weeks After ESI to mild cross-over No
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