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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Non-Linear Technologies.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Non-Linear Technologies
ClinicalTrials.gov Identifier:
NCT01053364
First received: January 19, 2010
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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 Intervention
Lumbar Spinal Stenosis
Device: NL-Prow interspinous spacer implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of NL-Prow Interspinous Spacer Device and Procedure

Resource links provided by NLM:


Further study details as provided by Non-Linear Technologies:

Primary Outcome Measures:
  • Accurate placement of the interspinous spacer confirmed by fluoroscopy [ Time Frame: Procedure completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in leg and or back pain and in walking capability compared to baseline [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Any device and or procedure related adverse events or complications [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implant Device: NL-Prow interspinous spacer implant
Interspinous spacer implant

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053364

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

No publications provided

Responsible Party: Lilach Eyal / Clinical Manager, Non-Linear Technologies
ClinicalTrials.gov Identifier: NCT01053364     History of Changes
Other Study ID Numbers: NL-PROW-01
Study First Received: January 19, 2010
Last Updated: January 4, 2011
Health Authority: Czech Republic: Ministry of Health

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

ClinicalTrials.gov processed this record on September 29, 2014