Last updated on June 2017

Assessing Superion Clinical Endpoints vs. Decompression


Brief description of study

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.

Detailed Study Description

STUDY DESIGN:This study is a prospective, multi-center, randomized controlled "Conditions of Use" clinical trial comparing the Superion® IDS to open, direct decompression in the treatment of subjects aged 45 or older suffering from moderate symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate LSS at one or two contiguous levels from L1 to L5, i.e. from the L1-L2 level to the L4-L5 level. A maximum of 20 investigative sites in the U.S. will enroll subjects into the trial using a 1:1 randomization assignment. Enrollment will include 358 subjects (152 per arm, plus 18% to account for lost to follow-up). An investigative site is defined as a facility or facilities in the same general geographic location if they are under the control of a local Institutional Review Board (IRB). After implantation of the Superion® IDS or performance of the direct decompression, each Investigator will be permitted to provide a postoperative care regimen based on the subject's specific need. The regimen may include, but need not be limited to: medications, a corset or brace, acupuncture, traction, physical therapy, chiropractic treatment, use of a TENS unit and massage therapy. The type and amount of the postoperative care will be collected. At each follow-up visit through 60 months, subjects will be interviewed to determine if they have experienced adverse events (AEs) since the previous follow-up visit. A neurological assessment will be performed for all patients at baseline and all follow-up visits. All subjects will be required to complete ZCQ, ODI, VAS, EQ-5D and the VertiFlex® Patient Satisfaction questionnaires to evaluate disability, function, pain, quality of life and satisfaction at each follow-up visit. Subjects are also required to complete a VAS questionnaire to evaluate pain status at discharge. The potential impact of spinal injections/nerve blocks use on the ZCQ was evaluated based on review of the medical literature. As these are potentially confounding of the ZCQ outcomes, epidural steroid injections or nerve block procedures at the treated level(s) will be deemed failures. Further, rhizotomy procedures at the treated level(s) will be deemed failures. With respect to spinal cord stimulators, because the use of a permanent implant would require a surgical procedure, this will be deemed a device failure. Radiographic evaluations will be performed at discharge, and at each scheduled follow-up visit and prior to any re-operations, in accordance with the Radiographic Evaluation Protocol. The Investigator may also obtain x-rays at unscheduled visits or to assess adverse events, if clinically indicated.

Clinical Study Identifier: NCT03048955

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Bradly Goodman, MD

Alabama Clinical Therapeutics, LLC
Birmingham, AL United States
  Connect »

Nathan Miller, MD

Coastal Pain Spinal Diagnostics
Carlsbad, CA United States
  Connect »

Richard Gayles, MD

Lake Nona Medical Arts
Celebration, FL United States
  Connect »

Pierce Nunley, MD

Spine Institute of Louisiana
Shreveport, LA United States
  Connect »

Guy Lee, MD

Rothman Institute
Willow Grove, PA United States
  Connect »