Clinical trial NCT00692276: Investigating Superion™ In Spinal Stenosis
Official title: A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Intermittent Claudication
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: VertiFlex, Incorporated
First posted: 2008-06-06
Enrollment: 391
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With Clinically Significant Improvement in Outcomes
timeFrame: Baseline and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Center for Neurosurgery
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Beverly Hills
country: United States
facility: D.I.S.C. Sports and Spine Center
state: California
city: Beverly Hills
country: United States
facility: Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
state: California
city: Laguna Hills
country: United States
facility: Orange County Neurosurgical Associates
state: California
city: Los Angeles
country: United States
facility: Brain and Spine Research Institute
state: California
city: Oceanside
country: United States
facility: Pacific Pain Medicine Consultants/Pacific Surgery Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
state: Colorado
city: Durango
country: United States
facility: Durango Orthopedic Associates, P.C./Spine Colorado
state: Colorado
city: Littleton
country: United States
facility: Colorado Spine And Scoliosis Institute
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: The George Washington Universtiy Medical Facility
state: District of Columbia
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Shrock Orthopedic Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Greater Baltimore Neurosurgical Associates at GBMA
state: Maryland
city: Peabody
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Minneapolis
country: United States
facility: Institute for Low Back and Neck Care
state: Minnesota
city: Phillipsburg
country: United States
facility: Orthopedics Associates of the Greater Lehigh Valley
state: New Jersey
city: Roseland
country: United States
facility: Spine Care and Rehabilitation, Inc.
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center, Dept. of Neurological Surgery
state: New York
city: Syracuse
country: United States
facility: Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
state: New York
city: Durham
country: United States
facility: Triangle Orthopaedic Associates
state: North Carolina
city: Eugene
country: United States
facility: NeuroSpine Institute, LLC
state: Oregon
city: Pottstown
country: United States
facility: Performance Spine and Sports Physicians
state: Pennsylvania
city: Willow Grove
country: United States
facility: OrthopaediCare (Abington Orthopaedic Specialists)
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Johnson City
country: United States
facility: East Tennessee Brain & Spine Center
state: Tennessee
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Seattle
country: United States
facility: Orthopedics International Spine
state: Washington
city: Charleston
country: United States
facility: The Center for Pain Relief, Inc
state: West Virginia
Study officials:
affiliation: Boston Scientific Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References:
citation: Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH. Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. BMC Musculoskelet Disord. 2014 Jul 5;15:221. doi: 10.1186/1471-2474-15-221.
citation: Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the Superion(R) Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011 Jul;8(4):419-26. doi: 10.1586/erd.11.24.