Trial Outcomes & Findings for Vertos Mild - Post Market Patient Outcomes (NCT NCT01076244)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

Baseline and six months

Results posted on

2013-04-02

Participant Flow

Patients were enrolled through one site (Center for Pain Relief) between March 2010 to January 2011.

Participant milestones

Participant milestones
Measure	Minimally Invasive Lumbar Decompression Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Overall Study STARTED	46
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vertos Mild - Post Market Patient Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minimally Invasive Lumbar Decompression n=46 Participants Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age Continuous	66.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and six months

Population: all available patients reporting at Month 6

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.

Outcome measures

Outcome measures
Measure	Minimally Invasive Lumbar Decompression n=42 Participants Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Pain as Measured by Visual Analog Scale (VAS).	2.17 units on a scale Interval 1.17 to 3.16

SECONDARY outcome

Timeframe: baseline and month 6

Population: All available patients at six months were analyzed.

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.

Outcome measures

Outcome measures
Measure	Minimally Invasive Lumbar Decompression n=42 Participants Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Improvement in Functional Mobility	13.43 units on a scale Interval 8.42 to 18.43

SECONDARY outcome

Timeframe: Baseline and month 6

Population: All patients having a month six report report were analyzed.

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.

Outcome measures

Outcome measures
Measure	Minimally Invasive Lumbar Decompression n=42 Participants Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).	1.07 units on a scale Interval 0.83 to 1.31

SECONDARY outcome

Timeframe: Baseline and month 6

Population: All available patients at the month 6 reporting period were analyzed.

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.

Outcome measures

Outcome measures
Measure	Minimally Invasive Lumbar Decompression n=42 Participants Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).	0.59 units on a scale Interval 0.34 to 0.84

Adverse Events

Minimally Invasive Lumbar Decompression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Deer

Center for Pain Relief

Phone: (304) 347-6144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place