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

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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Baxano iO-Flex® System

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iO-Flex	Device: Baxano iO-Flex® System; Decompressive lumbar surgery using Baxano iO-Flex® System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months
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%	6 months
Re-operation at the treatment level(s) at one year post-procedure	One year
Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects	Hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Visual Analog Scale scores compared to baseline	6 weeks, 3 months, 6 months, 12 months, 24 months
Changes in Zurich Claudication Questionnaire scores compared to baseline	6 weeks, 3, 6, 12, and 24 months
Changes in Oswestry Disability Index scores compared to baseline	6 weeks, 3, 6, 12, and 24 months
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	6, 12, and 24 months
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	Through 2 years

Collaborators and Investigators

• Sponsor: Baxano Surgical, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Lumbar spinal stenosis; Decompression; Lumbar spinal decompression; Lumbar spinal decompressive surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: CP-1318