Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression
STRiDE
1 other identifier
interventional
100
1 country
14
Brief Summary
The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedApril 23, 2014
April 1, 2014
3.7 years
April 18, 2011
April 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oswestry Disability Index (ODI)
Responder analysis
24 Months
Secondary Outcomes (7)
Operative success
Operative (day 1)
Oswestry Disability Index (ODI)
6, 12, 36, 48 and 60 months
Oswestry Disability Index (ODI)
6, 12, 24, 36, 48 and 60 months
Numerical Rating Scale (NRS)
6, 12, 24, 36, 48 and 60 months
Zurich Claudication Questionnaire (ZCQ)
6, 12, 24, 36, 48 and 60 months
- +2 more secondary outcomes
Study Arms (1)
Surgery
EXPERIMENTALDecompression using the iO-Flex® system
Interventions
Eligibility Criteria
You may qualify if:
- Adult (\> 18 years of age)
- Leg/buttock pain, with or without back pain
- Grade 1 degenerative spondylolisthesis (≤25% slippage)
- NRS pain score for leg pain of 4/10 or greater
- ODI score of 30/100 or greater
- Failed non-operative medical management for a period of at least 6 months
- Confirmed clinical diagnosis of lumbar spinal stenosis
- Confirmation of central and/or lateral recess stenosis with or without foraminal stenosis, at one level or at two adjacent levels from L2-S1, with concordant symptoms. Subjects with central and/or lateral recess stenosis and spondylolisthesis at one level, may have symptomatic central, lateral recess or foraminal stenosis treated at one adjacent level. A "below-the pedicle" pass to decompress a third segment can be completed provided laminotomies are performed at no more than 2 levels. Subjects that, following an intraoperative decision, have a 3-level laminotomy and decompression will not be considered enrolled. Confirmation of spinal stenosis is shown on MRI or CT scan with evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
- Ability to give voluntary, written informed consent to participate in this clinical investigation and ability to participate in follow up examinations and complete patient questionnaires
You may not qualify if:
- Back pain only
- Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
- History of pathologic fractures of the vertebrae
- Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
- Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
- Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
- Prior surgery of the lumbar spine
- Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
- Spondylolysis (pars fracture) at any level in the lumbar spine
- Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
- Vascular claudication in the lower extremities
- Cauda equina syndrome
- Evidence of active (systemic or local) infection at time of surgery
- Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
- Tumor in the spine or a malignant tumor except for basal cell carcinoma.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Eden Medical Center
Castro Valley, California, 94546, United States
Olympia Medical Center
Los Angeles, California, 90036, United States
Orange County Neurological Associates
Mission Viejo, California, 92691, United States
University California Irvine
Orange, California, 92868, United States
Southern California Orthopedic Institute
Van Nuys, California, 91405, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Medical Center of Trinity
Odessa, Florida, 33556, United States
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637, United States
Resurgens Orthopaedics
Cumming, Georgia, 30041, United States
Suburban Orthopedics
Bartlett, Illinois, 60103, United States
Indiana Spine Group
Carmel, Indiana, 46032, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
VCU Medical Center
Richmond, Virginia, 23219, United States
Tuckahoe Orthopedics
Richmond, Virginia, 23226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvain Palmer, M.D.
Neurological Surgery Medical Associates
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2011
First Posted
April 20, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2014
Last Updated
April 23, 2014
Record last verified: 2014-04