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

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00697827
First received: June 11, 2008
Last updated: June 5, 2012
Last verified: June 2012

June 11, 2008
June 5, 2012
June 2008
June 2011   (final data collection date for primary outcome measure)
Zurich Claudication Questionnaire(ZCQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00697827 on ClinicalTrials.gov Archive Site
Oswestry Disability Index (ODI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Stenosis
  • Device: Interspinous Spacer device
    Device: In-Space
  • Device: Interspinous Process Distraction Device
    Device: X STOP
  • Experimental: 1
    In-Space
    Intervention: Device: Interspinous Spacer device
  • Active Comparator: 2
    X STOP
    Intervention: Device: Interspinous Process Distraction Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00697827
INSP01
No
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