Back to resultsA Study of the In-Space Device for Treatment of Moderate Spinal Stenosis (In-Space)
Primary Purpose
Spinal Stenosis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Interspinous Spacer device
Interspinous Process Distraction Device
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis
Eligibility Criteria
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
Sites / Locations
- The Spine Institute
- Yale Orthopedics
- Institute for Low Back and Neck Care
- Cornell University Hospital
- OrthoCarolina Spine Center
- Temple University Hospital
- Neurosurgical Associates at Centennial Medical Center
- Texas Back Institute
- Neurosurgical Specialists, Inc.
- Madigan Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
In-Space
X STOP
Outcomes
Primary Outcome Measures
Zurich Claudication Questionnaire(ZCQ)
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
Oswestry Disability Index (ODI)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00697827
Brief Title
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Acronym
In-Space
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to low enrollment.
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthes USA HQ, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
In-Space
Arm Title
2
Arm Type
Active Comparator
Arm Description
X STOP
Intervention Type
Device
Intervention Name(s)
Interspinous Spacer device
Intervention Description
Device: In-Space
Intervention Type
Device
Intervention Name(s)
Interspinous Process Distraction Device
Intervention Description
Device: X STOP
Primary Outcome Measure Information:
Title
Zurich Claudication Questionnaire(ZCQ)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Spine Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Yale Orthopedics
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Institute for Low Back and Neck Care
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Cornell University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
OrthoCarolina Spine Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Neurosurgical Associates at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Neurosurgical Specialists, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98341
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
We'll reach out to this number within 24 hrs