The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
NCT ID: NCT01067014
Last Updated: 2013-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2010-02-28
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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iO-Flex
Baxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System
Interventions
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Baxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System
Eligibility Criteria
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Inclusion Criteria
1. Age ≥18 years
2. Leg/buttock pain with or without back pain
3. Failed nonoperative medical management
4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
6. Able and willing to give voluntary, written informed consent to participate in this clinical study
Exclusion Criteria
1. Back pain only
2. A diagnosis of central stenosis only
3. More than two levels requiring decompression
4. Fixed motor deficit
5. Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
7. Primary disc pathology and/or patients who will undergo a discectomy
8. Prior surgery of the lumbar spine at the level(s) of planned treatment
9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4)
10. Spondylolysis (pars fracture) at any level in the lumbar spine
11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25°
12. Symptomatic vascular claudication in the lower extremities
13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)
14. Evidence of active (systemic or local) infection at time of surgery
15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
16. Tumor in the spine or a malignant tumor except for basal cell carcinoma
17. Prisoner or transient
18. Recent history of known narcotic abuse
19. Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires
20. Involved in pending litigation of the spine or worker's compensation related to the back
21. Inability to communicate clearly in the English language
22. Morbid obesity (BMI \> 40)
23. Plans to relocate within the next 2 years
24. Pregnant or planning to become pregnant
25. Irreversible coagulopathy or bleeding disorder
a. Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.
26. Subject unwilling to undergo blood transfusion, if necessary
18 Years
ALL
No
Sponsors
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Baxano Surgical, Inc.
INDUSTRY
Responsible Party
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Locations
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Eden Medical Center
Castro Valley, California, United States
Olympia Medical Center
Los Angeles, California, United States
Watsonville Community Hospital
Watsonville, California, United States
Resurgens Orthopaedics
Cumming, Georgia, United States
Suburban Orthopedics
Bartlett, Illinois, United States
Spine Midwest, Inc.
Jefferson City, Missouri, United States
McCune-Brooks Regional Hospital
Joplin, Missouri, United States
Buffalo Spine Surgery
Lockport, New York, United States
Triangle Orthopaedic Associates
Chapel Hill, North Carolina, United States
Moses Cone Hospital
Greensboro, North Carolina, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, United States
Rothman Institute
Bensalem, Pennsylvania, United States
Easton Hospital
Easton, Pennsylvania, United States
Carolina Neurosurgery & Spine Center
Greenwood, South Carolina, United States
Neurospine Solutions, PC
Bristol, Tennessee, United States
Spine Works Institute
North Richland Hills, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Tuckahoe Orthopaedic Associates
Richmond, Virginia, United States
Countries
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Other Identifiers
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CP-1318
Identifier Type: -
Identifier Source: org_study_id