The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baxano Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT01067014
First received: February 9, 2010
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.


Condition Intervention
Lumbar Spinal Stenosis
Device: Baxano iO-Flex® System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Resource links provided by NLM:


Further study details as provided by Baxano Surgical, Inc.:

Primary Outcome Measures:
  • Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Re-operation at the treatment level(s) at one year post-procedure [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in Visual Analog Scale scores compared to baseline [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Changes in Zurich Claudication Questionnaire scores compared to baseline [ Time Frame: 6 weeks, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Changes in Oswestry Disability Index scores compared to baseline [ Time Frame: 6 weeks, 3, 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
iO-Flex Device: Baxano iO-Flex® System
Decompressive lumbar surgery using Baxano iO-Flex® System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at least 18 years of age presenting with failed conservative treatment for one or two level lumbar spinal stenosis

Criteria

Inclusion Criteria

Candidates for this study must meet ALL of the following 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

Candidates will be excluded from the evaluation if ANY of the following apply:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067014

Locations
United States, California
Eden Medical Center
Castro Valley, California, United States, 94546
Olympia Medical Center
Los Angeles, California, United States, 90036
Watsonville Community Hospital
Watsonville, California, United States, 95076
United States, Georgia
Resurgens Orthopaedics
Cumming, Georgia, United States, 30041
United States, Illinois
Suburban Orthopedics
Bartlett, Illinois, United States, 60103
United States, Missouri
Spine Midwest, Inc.
Jefferson City, Missouri, United States, 65101
McCune-Brooks Regional Hospital
Joplin, Missouri, United States, 64804
United States, New York
Buffalo Spine Surgery
Lockport, New York, United States, 14094
United States, North Carolina
Triangle Orthopaedic Associates
Chapel Hill, North Carolina, United States, 27514
Moses Cone Hospital
Greensboro, North Carolina, United States, 27401
Caldwell Memorial Hospital
Lenoir, North Carolina, United States, 28645
United States, Pennsylvania
Rothman Institute
Bensalem, Pennsylvania, United States, 19020
Easton Hospital
Easton, Pennsylvania, United States, 18017
United States, South Carolina
Carolina Neurosurgery & Spine Center
Greenwood, South Carolina, United States, 29646
United States, Tennessee
Neurospine Solutions, PC
Bristol, Tennessee, United States, 37620
United States, Texas
Spine Works Institute
North Richland Hills, Texas, United States, 76182
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Tuckahoe Orthopaedic Associates
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Baxano Surgical, Inc.
  More Information

No publications provided

Responsible Party: Baxano Surgical, Inc.
ClinicalTrials.gov Identifier: NCT01067014     History of Changes
Other Study ID Numbers: CP-1318
Study First Received: February 9, 2010
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baxano Surgical, Inc.:
Lumbar spinal stenosis
Decompression
Lumbar spinal decompression
Lumbar spinal decompressive surgery

Additional relevant MeSH terms:
Spinal Stenosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014