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:
Synthes USA HQ, Inc.
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Stenosis |
Device: Interspinous Spacer device Device: Interspinous Process Distraction Device |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis |
Resource links provided by NLM:
Further study details as provided by Synthes USA HQ, Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 44 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
In-Space
|
Device: Interspinous Spacer device
Device: In-Space
|
|
Active Comparator: 2
X STOP
|
Device: Interspinous Process Distraction Device
Device: X STOP
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697827
Locations
| United States, California | |
| The Spine Institute | |
| Santa Monica, California, United States, 90404 | |
| United States, Connecticut | |
| Yale Orthopedics | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Minnesota | |
| Institute for Low Back and Neck Care | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New York | |
| Cornell University Hospital | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| OrthoCarolina Spine Center | |
| Charlotte, North Carolina, United States, 28209 | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Tennessee | |
| Neurosurgical Associates at Centennial Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Texas Back Institute | |
| Plano, Texas, United States, 75093 | |
| United States, Virginia | |
| Neurosurgical Specialists, Inc. | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98341 | |
Sponsors and Collaborators
Synthes USA HQ, Inc.
More Information
No publications provided
| Responsible Party: | Synthes USA HQ, Inc. |
| ClinicalTrials.gov Identifier: | NCT00697827 History of Changes |
| Other Study ID Numbers: | INSP01 |
| Study First Received: | June 11, 2008 |
| Results First Received: | May 3, 2012 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013