Clinical trial NCT01067014: The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
Official title: The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar spinal stenosis
Decompression
Lumbar spinal decompression
Lumbar spinal decompressive surgery
Lead sponsor: Baxano Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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%
timeFrame: 6 months
measure: Re-operation at the treatment level(s) at one year post-procedure
timeFrame: One year
measure: Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects
timeFrame: Hospital discharge
Secondary outcomes:
measure: Changes in Visual Analog Scale scores compared to baseline
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Changes in Zurich Claudication Questionnaire scores compared to baseline
timeFrame: 6 weeks, 3, 6, 12, and 24 months
measure: Changes in Oswestry Disability Index scores compared to baseline
timeFrame: 6 weeks, 3, 6, 12, and 24 months
measure: 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
timeFrame: 6, 12, and 24 months
measure: 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
timeFrame: Through 2 years
Other outcomes:
Locations:
city: Castro Valley
country: United States
facility: Eden Medical Center
state: California
city: Los Angeles
country: United States
facility: Olympia Medical Center
state: California
city: Watsonville
country: United States
facility: Watsonville Community Hospital
state: California
city: Cumming
country: United States
facility: Resurgens Orthopaedics
state: Georgia
city: Bartlett
country: United States
facility: Suburban Orthopedics
state: Illinois
city: Jefferson City
country: United States
facility: Spine Midwest, Inc.
state: Missouri
city: Joplin
country: United States
facility: McCune-Brooks Regional Hospital
state: Missouri
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
city: Chapel Hill
country: United States
facility: Triangle Orthopaedic Associates
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Hospital
state: North Carolina
city: Lenoir
country: United States
facility: Caldwell Memorial Hospital
state: North Carolina
city: Bensalem
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Easton
country: United States
facility: Easton Hospital
state: Pennsylvania
city: Greenwood
country: United States
facility: Carolina Neurosurgery & Spine Center
state: South Carolina
city: Bristol
country: United States
facility: Neurospine Solutions, PC
state: Tennessee
city: North Richland Hills
country: United States
facility: Spine Works Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Tuckahoe Orthopaedic Associates
state: Virginia
Study officials:
References: