A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

Last updated: June 5, 2012
Sponsor: Synthes USA HQ, Inc.
Overall Status: Terminated

Phase

3

Condition

Spinal Stenosis

Spondylolisthesis

Treatment

N/A

Clinical Study ID

NCT00697827
INSP01
  • Ages > 50
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 50 years in age

  • Leg/buttock/groin pain, with or without back pain, that can be completely relieved byflexion such as when sitting in a chair.

  • Zurich Claudication Questionnaire Score ≥ 2.0,

  • Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis

  • Has completed at least 6 months conservative therapy

Exclusion

Exclusion Criteria:

  • Axial back pain only without leg/buttock/groin pain

  • Has had any prior lumbar spine surgery at any level

  • Significant scoliosis, defined as Cobb angle > 10°

  • Spondylolisthesis > Grade 1 or isthmic spondylolisthesis at affected level

  • Osteoporosis

  • Morbid obesity, defined as BMI > 40 kg/m2

Study Design

Total Participants: 44
Study Start date:
June 01, 2008
Estimated Completion Date:
June 30, 2011

Connect with a study center

  • The Spine Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Yale Orthopedics

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Institute for Low Back and Neck Care

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Cornell University Hospital

    New York, New York 10021
    United States

    Site Not Available

  • OrthoCarolina Spine Center

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Neurosurgical Associates at Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Back Institute

    Plano, Texas 75093
    United States

    Site Not Available

  • Neurosurgical Specialists, Inc.

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98341
    United States

    Site Not Available

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