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Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)

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ClinicalTrials.gov Identifier: NCT01338766
Recruitment Status : Unknown
Verified April 2014 by Baxano Surgical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 20, 2011
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Baxano Surgical, Inc.

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.

Condition or disease Intervention/treatment Phase
Radiculopathy Spondylolisthesis Lumbar Spinal Stenosis Procedure: Decompression using the iO-Flex® system Not Applicable

Detailed Description:

This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.

In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)
Study Start Date : April 2011
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Surgery
Decompression using the iO-Flex® system
Procedure: Decompression using the iO-Flex® system
Decompression using the iO-Flex® system




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 24 Months ]
    Responder analysis


Secondary Outcome Measures :
  1. Operative success [ Time Frame: Operative (day 1) ]
    Achieving intended decompression using the iO-Flex® System. The number of neural foramen in which the iO-Flex® System was used for decompression compared to the number in which an attempt was made but not completed.

  2. Oswestry Disability Index (ODI) [ Time Frame: 6, 12, 36, 48 and 60 months ]
    Responder analysis

  3. Oswestry Disability Index (ODI) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Comparison of ODI scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits

  4. Numerical Rating Scale (NRS) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Comparison of NRS scores for back and leg pain between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits

  5. Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Comparison of ZCQ scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits

  6. SF-36 Health Survey [ Time Frame: 6, 12, 24, 36, 48 and 60 months ]
    Comparison of SF-36 scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits

  7. Treatment survival rate [ Time Frame: Ongoing out to 60 months ]
    To characterize longevity of the treatment effect of a decompression using the iO-Flex® System.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (> 18 years of age)
  2. Leg/buttock pain, with or without back pain
  3. Grade 1 degenerative spondylolisthesis (≤25% slippage)
  4. NRS pain score for leg pain of 4/10 or greater
  5. ODI score of 30/100 or greater
  6. Failed non-operative medical management for a period of at least 6 months
  7. Confirmed clinical diagnosis of lumbar spinal stenosis
  8. 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.
  9. 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

Exclusion Criteria:

  1. Back pain only
  2. Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
  3. History of pathologic fractures of the vertebrae
  4. 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.
  5. 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.
  6. Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
  7. Prior surgery of the lumbar spine
  8. Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
  9. Spondylolysis (pars fracture) at any level in the lumbar spine
  10. Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
  11. Vascular claudication in the lower extremities
  12. Cauda equina syndrome
  13. Evidence of active (systemic or local) infection at time of surgery
  14. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
  15. Tumor in the spine or a malignant tumor except for basal cell carcinoma.
  16. Prisoner or transient
  17. Any significant psychological disturbance past or present, psychotic or neurotic that could impair the consent process or ability to complete subject self-report questionnaires
  18. Involved in pending litigation of the spine or worker's compensation related to the back
  19. Inability to communicate clearly in the English language
  20. Morbid obesity (BMI > 40)
  21. Pregnant, nursing, or planning on becoming pregnant.
  22. History of narcotic abuse
  23. Current involvement in another drug or device clinical trial
  24. Uncontrolled diabetes
  25. Irreversible coagulopathy or bleeding disorder (patients on anticoagulant therapy may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.)
  26. Plans to relocate in the next 2 years
  27. Subject unwilling to undergo a blood transfusion, if necessary

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338766


Locations
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United States, California
Eden Medical Center
Castro Valley, California, United States, 94546
Olympia Medical Center
Los Angeles, California, United States, 90036
Orange County Neurological Associates
Mission Viejo, California, United States, 92691
University California Irvine
Orange, California, United States, 92868
Southern California Orthopedic Institute
Van Nuys, California, United States, 91405
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
Medical Center of Trinity
Odessa, Florida, United States, 33556
Florida Orthopaedic Institute
Temple Terrace, Florida, United States, 33637
United States, Georgia
Resurgens Orthopaedics
Cumming, Georgia, United States, 30041
United States, Illinois
Suburban Orthopedics
Bartlett, Illinois, United States, 60103
United States, Indiana
Indiana Spine Group
Carmel, Indiana, United States, 46032
United States, Texas
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23219
Tuckahoe Orthopedics
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Baxano Surgical, Inc.
Investigators
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Principal Investigator: Sylvain Palmer, M.D. Neurological Surgery Medical Associates

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Responsible Party: Baxano Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01338766     History of Changes
Other Study ID Numbers: CP-1967
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Keywords provided by Baxano Surgical, Inc.:
spondylolisthesis
lumbar spinal stenosis
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Radiculopathy
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spondylolysis
Spondylosis