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

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: NCT00697827
Recruitment Status : Terminated (Study terminated due to low enrollment.)
First Posted : June 16, 2008
Results First Posted : June 5, 2012
Last Update Posted : June 11, 2012
Information provided by (Responsible Party):
Synthes USA HQ, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Device: Interspinous Spacer device Device: Interspinous Process Distraction Device Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
Study Start Date : June 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: 1
Device: Interspinous Spacer device
Device: In-Space

Active Comparator: 2
Device: Interspinous Process Distraction Device
Device: X STOP

Primary Outcome Measures :
  1. Zurich Claudication Questionnaire(ZCQ) [ Time Frame: 24 months ]
    The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of < 2.5 points for patient satisfaction at 24 months.

Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 24 months ]
    The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. There are 10 questions. The questions are designed in a way to show how the back or leg pain is affecting the patient's ability to manage in everyday life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. For this study,any improvement at 24 months compared to pre-operative baseline was determined as a success.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • ≥ 50 years in age
  • Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion 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 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

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): NCT00697827

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United States, California
The Spine Institute
Santa Monica, California, United States, 90404
United States, Connecticut
Yale Orthopedics
New Haven, Connecticut, United States, 06519
United States, Minnesota
Institute for Low Back and Neck Care
Minneapolis, Minnesota, United States, 55407
United States, New York
Cornell University Hospital
New York, New York, United States, 10021
United States, North Carolina
OrthoCarolina Spine Center
Charlotte, North Carolina, United States, 28209
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Neurosurgical Associates at Centennial Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
United States, Virginia
Neurosurgical Specialists, Inc.
Norfolk, Virginia, United States, 23510
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98341
Sponsors and Collaborators
Synthes USA HQ, Inc.
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Responsible Party: Synthes USA HQ, Inc. Identifier: NCT00697827    
Other Study ID Numbers: INSP01
First Posted: June 16, 2008    Key Record Dates
Results First Posted: June 5, 2012
Last Update Posted: June 11, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases