Study Stopped
Study terminated due to low enrollment.
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
In-Space
A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
1 other identifier
interventional
44
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2008
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 5, 2012
CompletedJune 11, 2012
June 1, 2012
3 years
June 11, 2008
May 3, 2012
June 5, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (1)
Oswestry Disability Index (ODI)
24 months
Study Arms (2)
1
EXPERIMENTALIn-Space
2
ACTIVE COMPARATORX STOP
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The Spine Institute
Santa Monica, California, 90404, United States
Yale Orthopedics
New Haven, Connecticut, 06519, United States
Institute for Low Back and Neck Care
Minneapolis, Minnesota, 55407, United States
Cornell University Hospital
New York, New York, 10021, United States
OrthoCarolina Spine Center
Charlotte, North Carolina, 28209, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Neurosurgical Associates at Centennial Medical Center
Nashville, Tennessee, 37203, United States
Texas Back Institute
Plano, Texas, 75093, United States
Neurosurgical Specialists, Inc.
Norfolk, Virginia, 23510, United States
Madigan Army Medical Center
Tacoma, Washington, 98341, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study terminated early secondary to low enrollment leading to small number of subjects available for analyses.
Results Point of Contact
- Title
- Ann Marie Simon
- Organization
- Synthes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 16, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 11, 2012
Results First Posted
June 5, 2012
Record last verified: 2012-06