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

NCT01067014 | Unknown

• 1 other identifier: CP-1318
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 18

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis; Decompression; Lumbar spinal decompression; Lumbar spinal decompressive surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (1)

iO-Flex

Device: Baxano iO-Flex® System

Interventions

Baxano iO-Flex® System DEVICE

Decompressive lumbar surgery using Baxano iO-Flex® System

iO-Flex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Candidates for this study must meet ALL of the following criteria:
• Age ≥18 years
• Leg/buttock pain with or without back pain
• Failed nonoperative medical management
• A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
• Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
• Able and willing to give voluntary, written informed consent to participate in this clinical study

You may not qualify if:

• Candidates will be excluded from the evaluation if ANY of the following apply:
• Back pain only
• A diagnosis of central stenosis only
• More than two levels requiring decompression
• Fixed motor deficit
• Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
• Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
• Primary disc pathology and/or patients who will undergo a discectomy
• Prior surgery of the lumbar spine at the level(s) of planned treatment
• Spondylolisthesis or degenerative 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 greater than or equal to 25°
• Symptomatic vascular claudication in the lower extremities
• Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)
• Evidence of active (systemic or local) infection at time of surgery

Sponsors & Collaborators

• Baxano Surgical, Inc.: lead

Study Sites (18)

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Olympia Medical Center

Los Angeles, California, 90036, United States

Location

Watsonville Community Hospital

Watsonville, California, 95076, United States

Location

Resurgens Orthopaedics

Cumming, Georgia, 30041, United States

Location

Suburban Orthopedics

Bartlett, Illinois, 60103, United States

Location

Spine Midwest, Inc.

Jefferson City, Missouri, 65101, United States

Location

McCune-Brooks Regional Hospital

Joplin, Missouri, 64804, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Triangle Orthopaedic Associates

Chapel Hill, North Carolina, 27514, United States

Location

Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

Rothman Institute

Bensalem, Pennsylvania, 19020, United States

Location

Easton Hospital

Easton, Pennsylvania, 18017, United States

Location

Carolina Neurosurgery & Spine Center

Greenwood, South Carolina, 29646, United States

Location

Neurospine Solutions, PC

Bristol, Tennessee, 37620, United States

Location

Spine Works Institute

North Richland Hills, Texas, 76182, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Tuckahoe Orthopaedic Associates

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 11, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

US (18)