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Dear TOPSTM Investigators,
We are initiating a communication plan to keep you informed about TOPSTM surgical technique tips, enrollment updates, protocol reminders, and other valuable information. Going forward, we will be sending you brief, periodic e-mails with the subject line that reads, “TOPSTM: Did You Know?”
For our first installment:
Did You Know?
Multi-level lumbar spinal stenosis does not necessarily exclude subjects from the TOPS study.
As outlined in the IDE Protocol:
“Patients which require minimal decompressive surgery at an adjacent level may have a laminotomy or soft tissue decompression so long as it does not compromise the stability of the adjacent segment.”
This means that you can perform non-destabilizing decompressions at one, two, three, or even four adjacent levels in addition to the instrumented decompression at the L3-4 or L4-5 index level.
An excellent example of this is Dr. Carl Lauryssen’s recent study patient who suffered from mild spinal stenosis at L2/3 and moderate to severe spinal stenosis with degenerative spondylolisthesis at L4/5. Dr. Lauryssen performed a laminotomy at L2/3 after a performing a wide decompression and TOPS procedure at L4/5 (see images below).
L4/5 stenosis with
So please keep in mind, multi-level pathology does not always mean exclusion.
If you have any questions about inclusion and exclusion criteria, please contact us at Impliant.
The Impliant Team
103 Carnegie Center, Suite 208
Princeton, NJ 08540