Investigating Superion™ In Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692276
• Other study ID #: 08-VISS-01
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: February 2017

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intermittent Claudication
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Superion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
• X-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis

Locations

Country	Name	City	State
United States	University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion	Aurora	Colorado
United States	Greater Baltimore Neurosurgical Associates at GBMA	Baltimore	Maryland
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	The Center for Pain Relief, Inc	Charleston	West Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	New England Center for Clinical Research	Cranston	Rhode Island
United States	Florida Research Associates, LLC	DeLand	Florida
United States	Durango Orthopedic Associates, P.C./Spine Colorado	Durango	Colorado
United States	Triangle Orthopaedic Associates	Durham	North Carolina
United States	NeuroSpine Institute, LLC	Eugene	Oregon
United States	Shrock Orthopedic Research	Fort Lauderdale	Florida
United States	East Tennessee Brain & Spine Center	Johnson City	Tennessee
United States	Orange County Neurosurgical Associates	Laguna Hills	California
United States	Colorado Spine And Scoliosis Institute	Littleton	Colorado
United States	Brain and Spine Research Institute	Los Angeles	California
United States	Institute for Low Back and Neck Care	Minneapolis	Minnesota
United States	Yale University	New Haven	Connecticut
United States	Pacific Pain Medicine Consultants/Pacific Surgery Center	Oceanside	California
United States	Sports Medicine North	Peabody	Massachusetts
United States	Orthopedics Associates of the Greater Lehigh Valley	Phillipsburg	New Jersey
United States	Arizona Center for Neurosurgery	Phoenix	Arizona
United States	Texas Back Institute	Plano	Texas
United States	Performance Spine and Sports Physicians	Pottstown	Pennsylvania
United States	Spine Care and Rehabilitation, Inc.	Roseland	New Jersey
United States	Orthopedics International Spine	Seattle	Washington
United States	Spine Institute of Louisiana	Shreveport	Louisiana
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	Tucson Orthopaedic Institute	Tucson	Arizona
United States	The George Washington Universtiy Medical Facility	Washington	District of Columbia
United States	OrthopaediCare (Abington Orthopaedic Specialists)	Willow Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	VertiFlex, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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