Vertos Mild - Post Market Patient Outcomes

Not Applicable

Completed

Conditions: Lumbar Spinal Stenosis

Interventions: Procedure: Minimally Invasive Lumbar Decompression

Registration Number: NCT01076244

Lead Sponsor: The Center for Pain Relief, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally invasive lumbar decompression	Minimally Invasive Lumbar Decompression	-

Primary Outcome Measures

Name	Time	Method
Pain as Measured by Visual Analog Scale (VAS).	Baseline and six months	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

Name	Time	Method
Improvement in Functional Mobility	baseline and month 6	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).	Baseline and month 6	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).	Baseline and month 6	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.

Trial Locations

Locations (2): The Center for Pain Relief, Inc.
🇺🇸
Charleston, West Virginia, United States
The Center for Pain Relief, Inc
🇺🇸
Charleston, West Virginia, United States