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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 11, 2008
Last Updated Date	June 5, 2012
Start Date ^ICMJE	June 2008
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 5, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: June 13, 2008)	Zurich Claudication Questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00697827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 5, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: June 13, 2008)	Oswestry Disability Index (ODI), [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Official Title ^ICMJE	A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Spinal Stenosis
Intervention ^ICMJE	Device: Interspinous Spacer device Device: In-Space Device: Interspinous Process Distraction Device Device: X STOP
Study Arm (s)	Experimental: 1 In-Space Intervention: Device: Interspinous Spacer device Active Comparator: 2 X STOP Intervention: Device: Interspinous Process Distraction Device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	44
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00697827
Other Study ID Numbers ^ICMJE	INSP01
Has Data Monitoring Committee	No
Responsible Party	Synthes USA HQ, Inc.
Study Sponsor ^ICMJE	Synthes USA HQ, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Synthes USA HQ, Inc.
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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