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Status:

COMPLETED

Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis

Lead Sponsor:

Impliant, Ltd.

Conditions:

Low Back Pain

Leg Pain

Eligibility:

All Genders

40-75 years

Phase:

PHASE3

Brief Summary

The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain...

Detailed Description

This study is being conducted to evaluate a new surgical implant (TOPS™ System, Impliant). The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the affected v...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Moderate to Severe lumbar spinal stenosis at a single level\* between L3 - L5, with radiographic confirmation of any one of the following on CT, MRI, plain x-ray or myelography:
  • Evidence of thecal sac and/or cauda equina compression
  • Evidence of nerve root impingement by either osseous or non-osseous elements;
  • Evidence of hypertrophic facets with canal encroachment Moderate/severe spinal stenosis is further defined radiographically as;
  • moderate canal stenosis is a 25-49% reduction in the A/P dimension of the central and/or lateral foramen when compared to adjacent (cephlad) level
  • Severe canal stenosis is defined as 50% or greater reduction in the A/P dimension of the central and/or lateral foramen when compared to the adjacent (cephlad) level \*\*Patients which require minimal decompressive surgery at an adjacent level, may have a laminonotmy or soft tissue resection as long as the decompression does not compromise the stability of the adjacent segment.
  • At least six (6) months of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage; administration of epidural/facet injections.
  • Age 40-75 years old (male or female).
  • Up to one prior surgery without instrumentation implanted at any lumbar vertebral level limited to the following:
  • IDET,
  • laminotomy,
  • laminectomy,
  • foraminotomy
  • Discectomy (that occurred at least three years ago without any reoccurrence of herniation)
  • Lower back pain and/or sciatica with or without spinal claudication.
  • VAS leg pain of at least 40/100 at baseline.
  • Oswestry Questionnaire score of at least 40/100 at baseline.
  • EXCLUSION CRITERIA:
  • Back or non-radicular leg pain of unknown etiology
  • Spondylolisthesis Grade II or higher
  • Stenosis caused by an extruded spinal disc fragment
  • Lytic spondylolisthesis
  • More than one (1) motion segment involved in the degenerative pathology to the extent that justifies its inclusion in the surgical procedure, unless a decompression alone can be done at that level without compromising stability.
  • Known allergy to titanium and/or polyurethane
  • Prior fusion surgery at any lumbar vertebral level with or without instrumentation
  • Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion cages)
  • Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.
  • Scoliosis of greater than ten (10) degrees (both angular and rotational)
  • Morbid obesity defined as a body mass index \> 40 or a weight more than 100 lbs. over ideal body weight.
  • Note: Additional inclusion/exclusion criteria are applied. Please contact Impliant for further details.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    450 Patients enrolled

    Trial Details

    Trial ID

    NCT00405691

    Start Date

    September 1 2006

    Last Update

    May 18 2011

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    Institute for Advanced Spinal Research In California

    Beverly Hills, California, United States, 90211

    2

    Century City Doctors Hospital

    Beverly Hills, California, United States, 90212

    3

    Seton Medical Center

    Daly City, California, United States, 94015

    4

    Yale University - School of Medicine

    New Haven, Connecticut, United States, 06519