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

Status unconfirmed

Conditions studied: Lumbar Spinal Stenosis

In brief

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.

Key facts

Study ID

NCT01067014

Run by

Baxano Surgical, Inc.

People needed

75

Starts

2010-02-01

Expected to finish

2014-12-01

Last updated by the study team

2013-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
• Tumor in the spine or a malignant tumor except for basal cell carcinoma
• Prisoner or transient
• Recent history of known narcotic abuse
• Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires
• Involved in pending litigation of the spine or worker's compensation related to the back
• Inability to communicate clearly in the English language
• Morbid obesity (BMI > 40)
• Plans to relocate within the next 2 years
• Pregnant or planning to become pregnant

Where it is running

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

Full record on ClinicalTrials.gov

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