Interspinous spacers reduce opioid consumption

[drusso]

Vertiflex Announces Publication Of Data Analysis Showing 85% Reduction In Patients Using Opioids After Treatment With Superion Indirect Decompression System - Vertiflex Spine

“With growing concerns over prescription opioid overuse and misuse, which can lead to addiction, any effective strategies that can decrease or even eliminate the need for opioid therapy in patients with LSS are welcome” said Tim Deer, M.D., an author on the publication and President and CEO, The Spine and Nerve Center of the Virginias."


Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis


Pierce D Nunley,1 Timothy R Deer,2 Ramsin M Benyamin,3 Peter S Staats,4 Jon E Block5

1Spine Institute of Louisiana, Shreveport, LA 71101, USA; 2Center for Pain Relief, Charleston, WV 25301, USA; 3Millennium Pain Center, Bloomington, IL 61704, USA; 4National Spine and Pain Centers, Rockville, MD 20852, USA; 5Jon Block, San Francisco, CA 94115, USA

Background: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS.
Methods: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use.
Results: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial.
Conclusion: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.

Keywords: interspinous spacer, Superion, lumbar spinal stenosis, opioids, neurogenic claudication, indirect decompression

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[BobBarker]

My anecdotal evidence corresponds with the study. A lot of these patients are the types that were taking less than 20meq and not taking the medication everyday. I had one guy that went from 60meq of oxycodone and 50mg nucynta bid to a couple tramadol/day. Everyone that is comfortable doing the more surgical pain procedures needs to get trained on Vertiflex. I had one lady that said “doc, you messed up.” —why? “I don’t need to come back anymore. The pain down my leg is gone.”

@gdub25

 

[Extralong]

Wow! Okay, maybe I should consider the Vertiflex.

 

[lobelsteve]

Vertiflex Announces Publication Of Data Analysis Showing 85% Reduction In Patients Using Opioids After Treatment With Superion Indirect Decompression System - Vertiflex Spine

“With growing concerns over prescription opioid overuse and misuse, which can lead to addiction, any effective strategies that can decrease or even eliminate the need for opioid therapy in patients with LSS are welcome” said Tim Deer, M.D., an author on the publication and President and CEO, The Spine and Nerve Center of the Virginias."


Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis


Pierce D Nunley,1 Timothy R Deer,2 Ramsin M Benyamin,3 Peter S Staats,4 Jon E Block5

1Spine Institute of Louisiana, Shreveport, LA 71101, USA; 2Center for Pain Relief, Charleston, WV 25301, USA; 3Millennium Pain Center, Bloomington, IL 61704, USA; 4National Spine and Pain Centers, Rockville, MD 20852, USA; 5Jon Block, San Francisco, CA 94115, USA

Background: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS.
Methods: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use.
Results: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial.
Conclusion: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.

Keywords: interspinous spacer, Superion, lumbar spinal stenosis, opioids, neurogenic claudication, indirect decompression

When the study is based on getting paid from the company to show some benefit to make more money for all parties involved....
Results are what they are.

Still, a slick procedure for ligamentous hypertrophy in those who cannot undergo open surgery. Should buy them 2-3 more years of adequate ambulation based on prior technologies for this.

 

[Timeoutofmind]

My anecdotal evidence corresponds with the study. A lot of these patients are the types that were taking less than 20meq and not taking the medication everyday. I had one guy that went from 60meq of oxycodone and 50mg nucynta bid to a couple tramadol/day. Everyone that is comfortable doing the more surgical pain procedures needs to get trained on Vertiflex. I had one lady that said “doc, you messed up.” —why? “I don’t need to come back anymore. The pain down my leg is gone.”

@gdub25

Question:
If u have spinous process fractures, like people did with xstop...what is ur plan? Do surgeons “fix” those or just let them be? I suppose you would have to explant as well so it’s not moving around in there bothering them?

Have you had to revise any that migrated?

 

[Timeoutofmind]

When the study is based on getting paid from the company to show some benefit to make more money for all parties involved....
Results are what they are.

Still, a slick procedure for ligamentous hypertrophy in those who cannot undergo open surgery. Should buy them 2-3 more years of adequate ambulation based on prior technologies for this.

I asked a spine surgeon after a lecture on these types of techniques (not industry sponsored) if he was a healthy 60yo with moderate central stenosis, and it was this or a single level lami...what would he take

He said vertiflex cuz reasonable success, you don’t mess up your virgin spine, and u can always go in later

 

[BobBarker]

I haven’t had any spinous process fractures. If you seat the device against the lamina with a mallett they are less likely. I would not treat the fx and would only get the device if it was causing issues/free floating.

 

[gdub25]

I will echo what Bob said, I have had very good success with this procedure and have all these patients very closely in an attempt to have a more scientific follow up and said of just saying “in my experience”. I started doing this about four months ago but so far every patient I have has done well with the exception of one in liked was mentioned above, we really haven’t lost anything and she can still go have surgery. This procedure has a 1 cm incision and literally takes 20 minutes, not a whole lot of downside here.