Investigating Superion™ In Spinal Stenosis

Not Applicable

Completed

Conditions: Lumbar Spinal Stenosis
Intermittent Claudication

Interventions: Device: Superion™ Interspinous Spacer
Device: X-STOP® IPD® Device

Registration Number: NCT00692276

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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.

Detailed Description: 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. The study endpoint is the rate of overall subject success at 24 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 391

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Superion™ Interspinous Spacer	Interspinous Process Spacer Device
2	X-STOP® IPD® Device	Interspinous Process Spacer Device

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Clinically Significant Improvement in Outcomes	Baseline and 24 months	Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) \[validated, condition-specific patient-reported questionnaire that captures data in three distinct domains\] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (32): Orange County Neurosurgical Associates
🇺🇸
Laguna Hills, California, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Greater Baltimore Neurosurgical Associates at GBMA
🇺🇸
Baltimore, Maryland, 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
Brain and Spine Research Institute
🇺🇸
Los Angeles, California, United States
Pacific Pain Medicine Consultants/Pacific Surgery Center
🇺🇸
Oceanside, California, United States
Durango Orthopedic Associates, P.C./Spine Colorado
🇺🇸
Durango, Colorado, United States
The George Washington Universtiy Medical Facility
🇺🇸
Washington, District of Columbia, United States
Florida Research Associates, LLC
🇺🇸
DeLand, Florida, United States
Shrock Orthopedic Research
🇺🇸
Fort Lauderdale, Florida, United States
Spine Institute of Louisiana
🇺🇸
Shreveport, Louisiana, 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
Performance Spine and Sports Physicians
🇺🇸
Pottstown, Pennsylvania, United States
OrthopaediCare (Abington Orthopaedic Specialists)
🇺🇸
Willow Grove, Pennsylvania, United States
New England Center for Clinical Research
🇺🇸
Cranston, Rhode Island, United States
East Tennessee Brain & Spine Center
🇺🇸
Johnson City, Tennessee, United States
Texas Back Institute
🇺🇸
Plano, Texas, United States
Orthopedics International Spine
🇺🇸
Seattle, Washington, United States
The Center for Pain Relief, Inc
🇺🇸
Charleston, West Virginia, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Colorado Spine And Scoliosis Institute
🇺🇸
Littleton, Colorado, United States
Arizona Center for Neurosurgery
🇺🇸
Phoenix, Arizona, United States
University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
🇺🇸
Aurora, Colorado, United States