Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis

January 4, 2011 updated by: Non-Linear Technologies

Feasibility Study of NL-Prow Interspinous Spacer Device and Procedure

The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Neurosurgery department, St. Anne's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women ≥50 years of age.
  • Symptoms of leg/buttock/groin pain, with or without back pain, that are exacerbated by lumbar extension and relieved in flexion.
  • Diagnosis of neurogenic intermittent claudication (NIC) (defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or standing) secondary to lumbar spinal canal stenosis at 1-2 lumbar levels (between L1 and L5), confirmed by dynamic X-Ray (showing sagital instability or rocking), and CT and/or MRI (showing central spinal canal narrowing and/or foraminal narrowing).
  • Has completed at least 6 months of conservative therapy, which may include but is not limited to, epidural steroid injections, oral steroids, NSAIDS, analgesics, physical therapy, spinal manipulation, bracing.
  • Appropriate candidate for lumbar surgical treatment using posterior approach.
  • Subject can walk independently 15 meters or more.
  • Subject is able to understand the risks and benefits of participating in the study.
  • Subject understands and has signed the study informed consent form.
  • Subject is physically and mentally willing and able to comply with the requirements of the study procedure and scheduled follow-up visits and testing.

Exclusion Criteria:

  • Severe symptomatic lumbar spinal stenosis at ≥2 level, requiring surgical intervention.
  • Prior lumbar spine surgery at any level.
  • Unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
  • Evidence that subject's symptoms are due to vascular claudication OR has significant peripheral vascular disease.
  • Significant instability of the lumbar spine at any level OR defined as translation of more than 3mm or 10 degrees of angular motion between flexion and extension on upright lateral radiographs.
  • Subject has an ankylosed segment at the affected level.
  • Significant scoliosis, defined as Cobb angle >25°.
  • Cauda equina syndrome.
  • Fixed motor deficit or known peripheral neuropathy demonstrated clinically.
  • Subject has degenerative neurologic disease.
  • Subject has any mass lesions.
  • Any evidence of spinal or systemic infection.
  • Subject has a history of spinous process fracture or pars interarticularis fractures or pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
  • Subject has history or radiographic evidence of 1 or more osteoporotic fractures in the spine.
  • Subject has severe osteoporosis of the spine, defined as bone mineral density (BMD) in the spine more than 2.5 SD below the mean of adult normals.
  • Subject is paraparetic.
  • Subject has a bleeding disorder.
  • Active systemic disease such as HIV, hepatitis, etc.
  • Subject is immunologically suppressed, or has received or is receiving 7.5 milligrams prednisone (or equivalent) daily for more than six months immediately prior to enrollment.
  • Extreme morbid obesity, defined as BMI >35 kg/m2.
  • Diagnosis of lumbar spinal stenosis which requires a direct neural decompression or surgical intervention other than those required to implant the experimental device.
  • Subject is not able to undergo MRI or tolerate closed MRI scan.
  • Known or suspected history of alcohol and/or drug abuse.
  • Life expectancy less than one year.
  • Active rheumatoid arthritis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Implant
Device: NL-Prow interspinous spacer implant
Interspinous spacer implant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Accurate placement of the interspinous spacer confirmed by fluoroscopy
Time Frame: Procedure completion
Procedure completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Improvement in leg and or back pain and in walking capability compared to baseline
Time Frame: One year
One year
Any device and or procedure related adverse events or complications
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Non-Linear Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zdenek Novak, MD, PhD, St. Anne's University Hospital Brno, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL-PROW-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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