Assessing Superion Clinical Endpoints vs. Decompression

NCT03048955 | Withdrawn FDA Device

• 1 other identifier: 15-VISS-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Spinal Stenosis, Lumbar Region With Neurogenic Claudication

Outcome Measures

Primary Outcomes (4)

• Composite Endpoint (Primary)

  Subjects in each arm (Superion® IDS and direct decompression) will be evaluated for success at each follow-up interval

  60 Months

• Zurich Claudication Questionnaire (ZCQ)

  Clinically significant improvement in outcomes compared to baseline

  60 Months

• No re-operations, revisions, removals, or supplemental fixation at the index level(s)

  Review in outcomes compared to baseline

  60 Months

• Epidural steroid injections for the treated level(s)

  Review in outcomes compared to baseline

  60 Months

Study Arms (2)

Indirect Decompression System

ACTIVE COMPARATOR

Superion® IDS surgical procedure

Device: Superion® IDS

Direct decompression Surgery

ACTIVE COMPARATOR

Open, direct decompression surgical procedure

Procedure: Direct decompression Surgery

Interventions

Superion® IDS DEVICE

Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve

Indirect Decompression System

Direct decompression Surgery PROCEDURE

A surgical procedure - the control

Direct decompression Surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• VertiFlex, Incorporated: lead

Study Sites (5)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35335, United States

Location

Coastal Pain Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

Lake Nona Medical Arts

Celebration, Florida, 32827, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Rothman Institute

Willow Grove, Pennsylvania, 19090, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, randomized, controlled

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: February 9, 2017
• Study Start: February 8, 2017
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2025
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)