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.

June 11, 2008
June 16, 2008
May 3, 2012
June 5, 2012
June 11, 2012
June 2008
June 2011   (Final data collection date for primary outcome measure)
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.
Zurich Claudication Questionnaire [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00697827 on Archive Site
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.
Oswestry Disability Index (ODI), [ Time Frame: 24 months ]
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A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Stenosis
  • Device: Interspinous Spacer device
    Device: In-Space
  • Device: Interspinous Process Distraction Device
    Device: X STOP
  • Experimental: 1
    Intervention: Device: Interspinous Spacer device
  • Active Comparator: 2
    X STOP
    Intervention: Device: Interspinous Process Distraction Device
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Synthes USA HQ, Inc.
Synthes USA HQ, Inc.
Not Provided
Not Provided
Synthes USA HQ, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP