Spinal Stenosis, Lumbar Region With Neurogenic Claudication Clinical Trial
Official title:
A 2 and 5 Year Comparative Evaluation of Clinical Outcomes in the Treatment of Moderate Lumbar Spinal Stenosis With the Superion® Indirect Decompression System (IDS) vs. Direct Decompression Surgery for FDA Actual Conditions of Use 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.
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.
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