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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01053364
Recruitment Status : Unknown
Verified January 2011 by Non-Linear Technologies.
Recruitment status was:  Active, not recruiting
First Posted : January 21, 2010
Last Update Posted : January 5, 2011
Information provided by:
Non-Linear Technologies

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Device: NL-Prow interspinous spacer implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of NL-Prow Interspinous Spacer Device and Procedure
Study Start Date : January 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Implant Device: NL-Prow interspinous spacer implant
Interspinous spacer implant

Primary Outcome Measures :
  1. Accurate placement of the interspinous spacer confirmed by fluoroscopy [ Time Frame: Procedure completion ]

Secondary Outcome Measures :
  1. Improvement in leg and or back pain and in walking capability compared to baseline [ Time Frame: One year ]
  2. Any device and or procedure related adverse events or complications [ Time Frame: One year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01053364

Czech Republic
Neurosurgery department, St. Anne's University Hospital
Brno, Czech Republic, 656 91
Sponsors and Collaborators
Non-Linear Technologies
Principal Investigator: Zdenek Novak, MD, PhD St. Anne's University Hospital Brno, Czech Republic

Responsible Party: Lilach Eyal / Clinical Manager, Non-Linear Technologies Identifier: NCT01053364     History of Changes
Other Study ID Numbers: NL-PROW-01
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases