Assessing Superion Clinical Endpoints vs. Decompression (ASCEND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03048955|
Recruitment Status : Withdrawn (FDA and Sponsor closed trial. New post-marketing approval trial in development.)
First Posted : February 9, 2017
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis, Lumbar Region With Neurogenic Claudication||Device: Superion® IDS Procedure: Direct decompression Surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, multi-center, randomized, controlled|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 8, 2017|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2025|
Active Comparator: Indirect Decompression System
Superion® IDS surgical procedure
Device: Superion® IDS
Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve
Active Comparator: Direct decompression Surgery
Open, direct decompression surgical procedure
Procedure: Direct decompression Surgery
A surgical procedure - the control
- Composite Endpoint (Primary) [ Time Frame: 60 Months ]Subjects in each arm (Superion® IDS and direct decompression) will be evaluated for success at each follow-up interval
- Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 60 Months ]Clinically significant improvement in outcomes compared to baseline
- No re-operations, revisions, removals, or supplemental fixation at the index level(s) [ Time Frame: 60 Months ]Review in outcomes compared to baseline
- Epidural steroid injections for the treated level(s) [ Time Frame: 60 Months ]Review in outcomes compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048955
|United States, Alabama|
|Alabama Clinical Therapeutics, LLC|
|Birmingham, Alabama, United States, 35335|
|United States, California|
|Coastal Pain Spinal Diagnostics|
|Carlsbad, California, United States, 92009|
|United States, Florida|
|Lake Nona Medical Arts|
|Celebration, Florida, United States, 32827|
|United States, Louisiana|
|Spine Institute of Louisiana|
|Shreveport, Louisiana, United States, 71101|
|United States, Pennsylvania|
|Willow Grove, Pennsylvania, United States, 19090|