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Investigating Superion™ In Spinal Stenosis

Primary Purpose

Lumbar Spinal Stenosis, Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Superion™ Interspinous Spacer
X-STOP® IPD® Device
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Center for Neurosurgery
  • Tucson Orthopaedic Institute
  • D.I.S.C. Sports and Spine Center
  • Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
  • Orange County Neurosurgical Associates
  • Brain and Spine Research Institute
  • Pacific Pain Medicine Consultants/Pacific Surgery Center
  • University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
  • Durango Orthopedic Associates, P.C./Spine Colorado
  • Colorado Spine And Scoliosis Institute
  • Yale University
  • The George Washington Universtiy Medical Facility
  • Florida Research Associates, LLC
  • Shrock Orthopedic Research
  • Rush University Medical Center
  • Spine Institute of Louisiana
  • Greater Baltimore Neurosurgical Associates at GBMA
  • Sports Medicine North
  • Institute for Low Back and Neck Care
  • Orthopedics Associates of the Greater Lehigh Valley
  • Spine Care and Rehabilitation, Inc.
  • Stony Brook University Medical Center, Dept. of Neurological Surgery
  • Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
  • Triangle Orthopaedic Associates
  • NeuroSpine Institute, LLC
  • Performance Spine and Sports Physicians
  • OrthopaediCare (Abington Orthopaedic Specialists)
  • New England Center for Clinical Research
  • East Tennessee Brain & Spine Center
  • Texas Back Institute
  • Orthopedics International Spine
  • The Center for Pain Relief, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Interspinous Process Spacer Device

Interspinous Process Spacer Device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2008
Last Updated
November 12, 2020
Sponsor
Boston Scientific Corporation
Collaborators
VertiFlex, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00692276
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
VertiFlex, Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Intermittent Claudication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Interspinous Process Spacer Device
Arm Title
2
Arm Type
Active Comparator
Arm Description
Interspinous Process Spacer Device
Intervention Type
Device
Intervention Name(s)
Superion™ Interspinous Spacer
Intervention Description
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Intervention Type
Device
Intervention Name(s)
X-STOP® IPD® Device
Intervention Description
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Primary Outcome Measure Information:
Title
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Description
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
Time Frame
Baseline and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Center for Neurosurgery
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
D.I.S.C. Sports and Spine Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Orange County Neurosurgical Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653-3665
Country
United States
Facility Name
Brain and Spine Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Pacific Pain Medicine Consultants/Pacific Surgery Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Durango Orthopedic Associates, P.C./Spine Colorado
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Colorado Spine And Scoliosis Institute
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
The George Washington Universtiy Medical Facility
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Florida Research Associates, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Shrock Orthopedic Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Greater Baltimore Neurosurgical Associates at GBMA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Sports Medicine North
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Institute for Low Back and Neck Care
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States
Facility Name
Orthopedics Associates of the Greater Lehigh Valley
City
Phillipsburg
State/Province
New Jersey
ZIP/Postal Code
08865
Country
United States
Facility Name
Spine Care and Rehabilitation, Inc.
City
Roseland
State/Province
New Jersey
ZIP/Postal Code
07068
Country
United States
Facility Name
Stony Brook University Medical Center, Dept. of Neurological Surgery
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Triangle Orthopaedic Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
NeuroSpine Institute, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Performance Spine and Sports Physicians
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
OrthopaediCare (Abington Orthopaedic Specialists)
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
East Tennessee Brain & Spine Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Orthopedics International Spine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
The Center for Pain Relief, Inc
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24996648
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.
Results Reference
derived
PubMed Identifier
21728727
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.
Results Reference
derived

Learn more about this trial

Investigating Superion™ In Spinal Stenosis

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