Assessing Superion Clinical Endpoints vs. Decompression

Withdrawn before enrolling · Not applicable

Conditions studied: Spinal Stenosis, Lumbar Region With Neurogenic Claudication

In brief

PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.

Key facts

Study ID

NCT03048955

Run by

VertiFlex, Incorporated

People needed

0

Starts

2017-02-08

Expected to finish

2025-07-31

Last updated by the study team

2019-06-12

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects ≥ 45 years of age.
• Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
• Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months, without relief.
• 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 access), and the nerve root canal (foraminal).
• Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as ≤50% reduction in lateral/central foramen.
• Must present with moderately impaired Physical Function (PF) defined as a score of ≥ 2.0 of the Zurich Claudication Questionnaire (ZCQ).
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
• Note: In Criteria #5, all imaging used to confirm LSS should be completed within 4 weeks prior to enrollment. Radiographic confirmation of LSS may include MRI and/or CT.

You may not qualify if…

• Axial back pain only.
• Fixed motor deficit in lower extremity(ies).
• Diagnosis of lumbar spinal stenosis which, if the patient were randomized to the Superion arm, would not require any direct neural decompression or surgical intervention other than that required to implant the Superion® device or if randomized to the direct decompression arm, would not require a decompression procedure which would create significant instability requiring spinal fusion, with or without instrumentation.
• 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° angulation through flexion/extension films.
• Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
• Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).
• Spondylosis (pars fracture) at the treatment level(s).
• Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.
• Osteoporosis, defined as a DEXA bone density measurement T score ≤ -2.5.
• Morbid obesity, defined as Body Mass Index (BMI) >40kg/m2.
• Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).
• Prior surgery of the lumbar spine at the treatment level(s).
• Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
• Active (systemic, or local in disc or spine) infection at time of surgery.
• Active systemic disease such as AIDS, HIV, hepatitis, etc.
• Paget's disease at involved segment or metastasis to the vertebrae, osteomalacia, or other metabolic bone disease.
• Currently undergoing immunosuppressive therapy or long-term steroid use.
• Known allergy to titanium or titanium alloys.
• Tumor in the spine or a malignant tumor except for basal cell carcinoma.
• Known or suspected history of alcohol and/or drug abuse.
• Prisoner or transient.
• Life expectancy less than two years.

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Coastal Pain Spinal Diagnostics — Carlsbad, California, United States
• Lake Nona Medical Arts — Celebration, Florida, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Rothman Institute — Willow Grove, Pennsylvania, United States

Full record on ClinicalTrials.gov

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