Status:
COMPLETED
Investigating Superion™ In Spinal Stenosis
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
VertiFlex, Incorporated
Conditions:
Lumbar Spinal Stenosis
Intermittent Claudication
Eligibility:
All Genders
45+ years
Phase:
NA
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 suffer...
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 suffer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00692276
Start Date
June 1 2008
End Date
February 1 2017
Last Update
November 16 2020
Active Locations (32)
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1
Arizona Center for Neurosurgery
Phoenix, Arizona, United States, 85020
2
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
3
D.I.S.C. Sports and Spine Center
Beverly Hills, California, United States, 90211
4
Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
Beverly Hills, California, United States, 90211