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Vertos Mild - Post Market Patient Outcomes

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimally Invasive Lumbar Decompression
Sponsored by
The Center for Pain Relief, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
  • Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
  • Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
  • Central canal cross sectional area clearly reduced per MRI/CT report
  • If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
  • Able to walk at least 10 feet unaided before being limited by pain
  • Available to complete 26 weeks of follow up
  • A signed Consent Form is obtained from the patient
  • Adults 18 years of age or older

Exclusion Criteria:

  • Prior surgery at the intended treatment level
  • Compound fracture with intraspinal retropulsion contributing to spinal stenosis
  • Disabling back or leg pain from causes other than lumbar spinal stenosis
  • Disc protrusion or osteophyte formation severe enough to confound study outcome
  • Facet hypertrophy severe enough to confound study outcome
  • Bleeding disorders and/or current use of anti-coagulants
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
  • Epidural steroids with 3 weeks prior to procedure
  • Inability of patient to lie prone for any reason with anesthesia support
  • Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
  • Dementia and/or inability to give informed consent
  • Pregnant and/or breastfeeding
  • On workman's Compensation or considering litigation associated with back pain

Sites / Locations

  • The Center for Pain Relief, Inc.
  • The Center for Pain Relief, Inc

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimally invasive lumbar decompression

Arm Description

Outcomes

Primary Outcome Measures

Pain as Measured by Visual Analog Scale (VAS).
A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.

Secondary Outcome Measures

Improvement in Functional Mobility
Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.

Full Information

First Posted
February 24, 2010
Last Updated
February 22, 2013
Sponsor
The Center for Pain Relief, Inc.
Collaborators
Vertos Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01076244
Brief Title
Vertos Mild - Post Market Patient Outcomes
Official Title
Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Center for Pain Relief, Inc.
Collaborators
Vertos Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.
Detailed Description
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally invasive lumbar decompression
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Lumbar Decompression
Intervention Description
This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
Primary Outcome Measure Information:
Title
Pain as Measured by Visual Analog Scale (VAS).
Description
A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
Time Frame
Baseline and six months
Secondary Outcome Measure Information:
Title
Improvement in Functional Mobility
Description
Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
Time Frame
baseline and month 6
Title
Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
Description
As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
Time Frame
Baseline and month 6
Title
Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
Description
For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.
Time Frame
Baseline and month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20% Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report Central canal cross sectional area clearly reduced per MRI/CT report If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator Able to walk at least 10 feet unaided before being limited by pain Available to complete 26 weeks of follow up A signed Consent Form is obtained from the patient Adults 18 years of age or older Exclusion Criteria: Prior surgery at the intended treatment level Compound fracture with intraspinal retropulsion contributing to spinal stenosis Disabling back or leg pain from causes other than lumbar spinal stenosis Disc protrusion or osteophyte formation severe enough to confound study outcome Facet hypertrophy severe enough to confound study outcome Bleeding disorders and/or current use of anti-coagulants Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment Epidural steroids with 3 weeks prior to procedure Inability of patient to lie prone for any reason with anesthesia support Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes Dementia and/or inability to give informed consent Pregnant and/or breastfeeding On workman's Compensation or considering litigation associated with back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy R Deer, MD
Organizational Affiliation
Center for Pain Relief, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Pain Relief, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
The Center for Pain Relief, Inc
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

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Vertos Mild - Post Market Patient Outcomes

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