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?”

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For our first installment:

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Did You Know?
Multi-level lumbar spinal stenosis does not necessarily exclude subjects from the TOPS study.

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As outlined in the IDE Protocol:

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“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.”

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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.

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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).
 

Pre-Op MRI
L2/3 stenosis
L4/5 stenosis with
degenerative spondylolisthesis

 Post-Op X-Ray
L4/5 TOPS

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.

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The Impliant Team
Impliant Inc.
103 Carnegie Center, Suite 208
Princeton, NJ 08540
Tel: 609.779.6800       
Fax:609.779.6805