Investigating Superion™ In Spinal Stenosis
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
1 other identifier
interventional
391
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
August 25, 2020
CompletedNovember 16, 2020
November 1, 2020
8.7 years
June 4, 2008
August 10, 2020
November 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Clinically Significant Improvement in Outcomes
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
Baseline and 24 months
Study Arms (2)
1
EXPERIMENTALInterspinous Process Spacer Device
2
ACTIVE COMPARATORInterspinous Process Spacer Device
Interventions
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- VertiFlex, Incorporatedcollaborator
Study Sites (32)
Arizona Center for Neurosurgery
Phoenix, Arizona, 85020, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
D.I.S.C. Sports and Spine Center
Beverly Hills, California, 90211, United States
Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
Beverly Hills, California, 90211, United States
Orange County Neurosurgical Associates
Laguna Hills, California, 92653-3665, United States
Brain and Spine Research Institute
Los Angeles, California, 90027, United States
Pacific Pain Medicine Consultants/Pacific Surgery Center
Oceanside, California, 92056, United States
University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
Aurora, Colorado, 80045, United States
Durango Orthopedic Associates, P.C./Spine Colorado
Durango, Colorado, 81301, United States
Colorado Spine And Scoliosis Institute
Littleton, Colorado, 80122, United States
Yale University
New Haven, Connecticut, 06520, United States
The George Washington Universtiy Medical Facility
Washington D.C., District of Columbia, 20037, United States
Florida Research Associates, LLC
DeLand, Florida, 32720, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101, United States
Greater Baltimore Neurosurgical Associates at GBMA
Baltimore, Maryland, 21204, United States
Sports Medicine North
Peabody, Massachusetts, 01960, United States
Institute for Low Back and Neck Care
Minneapolis, Minnesota, 55425, United States
Orthopedics Associates of the Greater Lehigh Valley
Phillipsburg, New Jersey, 08865, United States
Spine Care and Rehabilitation, Inc.
Roseland, New Jersey, 07068, United States
Stony Brook University Medical Center, Dept. of Neurological Surgery
Stony Brook, New York, 11794, United States
Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
Syracuse, New York, 13202, United States
Triangle Orthopaedic Associates
Durham, North Carolina, 27704, United States
NeuroSpine Institute, LLC
Eugene, Oregon, 97401, United States
Performance Spine and Sports Physicians
Pottstown, Pennsylvania, 19464, United States
OrthopaediCare (Abington Orthopaedic Specialists)
Willow Grove, Pennsylvania, 19090, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
East Tennessee Brain & Spine Center
Johnson City, Tennessee, 37604, United States
Texas Back Institute
Plano, Texas, 75093, United States
Orthopedics International Spine
Seattle, Washington, 98104, United States
The Center for Pain Relief, Inc
Charleston, West Virginia, 25301, United States
Related Publications (2)
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.
PMID: 24996648DERIVEDLoguidice 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.
PMID: 21728727DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steve Reitzler
- Organization
- Vertiflex
Study Officials
- STUDY DIRECTOR
Roshini Jain
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
November 16, 2020
Results First Posted
August 25, 2020
Record last verified: 2020-11