Overview

This trial is active, not recruiting.

Conditions lumbar spinal stenosis, intermittent claudication
Treatments superion™ interspinous spacer, x-stop® ipd® device
Sponsor VertiFlex, Incorporated
Start date June 2008
End date December 2016
Trial size 400 participants
Trial identifier NCT00692276, 08-VISS-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Interspinous Process Spacer Device
superion™ interspinous spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
(Active Comparator)
Interspinous Process Spacer Device
x-stop® ipd® device
Implantation of interspinous process spacer to treat lumbar spinal stenosis

Primary Outcomes

Measure
Effectiveness will be determined based on Zurich Claudication Questionnaire (ZCQ) results at 24 months relative to pre-treatment values
time frame: 24 months

Secondary Outcomes

Measure
Oswestry Disability Index
time frame: 24 months

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by VertiFlex, Incorporated.