Investigating Superion™ In Spinal Stenosis

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis, Intermittent Claudication

In brief

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Key facts

Study ID

NCT00692276

Run by

Boston Scientific Corporation

People needed

391

Starts

2008-06-01

Expected to finish

2017-02-01

Last updated by the study team

2020-11-16

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects ≥ 45 years of age
• Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
• Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
• Must be able to sit for 50 minutes without pain and to walk 50 feet or more

You may not qualify if…

• Axial back pain only
• Fixed motor deficit
• Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
• Unremitting pain in any spinal position
• Significant peripheral neuropathy or acute denervation secondary to radiculopathy
• Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
• Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
• Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
• Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
• Spondylolysis (pars fracture)
• Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
• Insulin-dependent diabetes mellitus
• Prior surgery of the lumbar spine
• Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
• Infection in the disc or spine, past or present
• 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
• Involved in pending litigation of the spine or worker's compensation related to the back

Where it is running

• Arizona Center for Neurosurgery — Phoenix, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• D.I.S.C. Sports and Spine Center — Beverly Hills, California, United States
• Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research — Beverly Hills, California, United States
• Orange County Neurosurgical Associates — Laguna Hills, California, United States
• Brain and Spine Research Institute — Los Angeles, California, United States
• Pacific Pain Medicine Consultants/Pacific Surgery Center — Oceanside, California, United States
• University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion — Aurora, Colorado, United States
• Durango Orthopedic Associates, P.C./Spine Colorado — Durango, Colorado, United States
• Colorado Spine And Scoliosis Institute — Littleton, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• The George Washington Universtiy Medical Facility — Washington D.C., District of Columbia, United States
• Florida Research Associates, LLC — DeLand, Florida, United States
• Shrock Orthopedic Research — Fort Lauderdale, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Greater Baltimore Neurosurgical Associates at GBMA — Baltimore, Maryland, United States
• Sports Medicine North — Peabody, Massachusetts, United States
• Institute for Low Back and Neck Care — Minneapolis, Minnesota, United States
• Orthopedics Associates of the Greater Lehigh Valley — Phillipsburg, New Jersey, United States
• Spine Care and Rehabilitation, Inc. — Roseland, New Jersey, United States
• Stony Brook University Medical Center, Dept. of Neurological Surgery — Stony Brook, New York, United States
• Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care — Syracuse, New York, United States
• Triangle Orthopaedic Associates — Durham, North Carolina, United States
• NeuroSpine Institute, LLC — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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