Vertos Mild - Post Market Patient Outcomes

Lumbar Spinal Stenosis Clinical Trial

Official title:

Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076244
• Other study ID #: #D1
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 22, 2013
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: The Center for Pain Relief, Inc.
• 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 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.

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.

Other known NCT identifiers

• NCT01130350

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Minimally Invasive Lumbar Decompression
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.

Locations

Country	Name	City	State
United States	The Center for Pain Relief, Inc	Charleston	West Virginia
United States	The Center for Pain Relief, Inc.	Charleston	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Pain Relief, Inc.	Vertos Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and six months	No
Secondary	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.	baseline and month 6	No
Secondary	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.	Baseline and month 6	No
Secondary	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.	Baseline and month 6	No