Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis

Nunley, Pierce D.; Patel, Vikas V.; Orndorff, Douglas G.; Lavelle, William F.; Block, Jon E.; Geisler, Fred H.

doi:10.2147/cia.s143503

Cited by 47 publications

(36 citation statements)

References 17 publications

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“…Additionally, 73% of patients reported improvements in leg VAS scores over baseline and 69% in back VAS scores. At 5 years, 84% ( n = 88) of patients treated with the S‐IDS demonstrated clinically significant success on at least 2 of the 3 domains of the ZCQ, 80% had improvements over baseline in leg pain and 65% in back pain …”

Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

“…In the 2005 Spine publication, improvements (≥15% improvement) in the ODI were noted in 65% of the subjects treated with the S‐IDS . Improvements in ODI score were sustained at 4 and 5 years ; 62% of subjects at 4 years and 65% at 5 years showed clinically significant improvements over baseline . It should be noted that although the literature has focused on comparing spacer devices with similar features, there has not been a direct comparison of the S‐IDS to decompression methods (percutaneous or open), merely noninferiority studies of the S‐IDS compared to the X‐ISS.…”

Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

“…At 3 years, the proportion of S-IDS patients (52.5%) achieving the primary endpoints was significantly greater than that of X-ISS patients (38%; P = 0.023). In 2017, the 4-year data were published by Nunley et al 89 At 4 years, 84.3% of patients (n = 89) treated with the S-IDS showed clinically significant success on at least 2 of the 3 domains of the ZCQ. Additionally, 73% of patients reported improvements in leg VAS scores over baseline and 69% in back VAS scores.…”

Section: Interspinous Spacers For Indirect Lumbar Decompressionmentioning

confidence: 99%

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The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Deer¹,

Grider

Pope

et al. 2018

Pain Practice

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Background Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options. Methods The Lumbar Spinal Stenosis Consensus Group convened to evaluate the peer‐reviewed literature as the basis for making minimally invasive spine treatment (MIST) recommendations. Eleven consensus points were clearly defined with evidence strength, recommendation grade, and consensus level using U.S. Preventive Services Task Force criteria. The Consensus Group also created a treatment algorithm. Literature searches yielded 9 studies (2 randomized controlled trials [RCTs]; 7 observational studies, 4 prospective and 3 retrospective) of minimally invasive spine treatments, and 1 RCT for spacers. Results The LSS treatment choice is dependent on the degree of stenosis; spinal or anatomic level; architecture of the stenosis; severity of the symptoms; failed, past, less invasive treatments; previous fusions or other open surgical approaches; and patient comorbidities. There is Level I evidence for percutaneous image‐guided lumbar decompression as superior to lumbar epidural steroid injection, and 1 RCT supported spacer use in a noninferiority study comparing 2 spacer products currently available. Conclusions MISTs should be used in a judicious and algorithmic fashion to treat LSS, based on the evidence of efficacy and safety in the peer‐reviewed literature. The MIST Consensus Group recommend that these procedures be used in a multimodal fashion as part of an evidence‐based decision algorithm.

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Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

Section: Therapies To Consider For the Treatment Algorithmmentioning

confidence: 99%

Section: Interspinous Spacers For Indirect Lumbar Decompressionmentioning

confidence: 99%

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The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Deer¹,

Grider

Pope

et al. 2018

Pain Practice

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“…IPD treatment has been shown to provide durable condition-specific symptom amelioration through 5 years of follow-up [ 6 ]. The current findings extend these previous results and demonstrate significant improvement in overall well-being following IPD, particularly in the physical function domains of quality of life.…”

Section: Discussionmentioning

confidence: 99%

Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis

Nunley

Patel

Orndorff

et al. 2018

Minimally Invasive Surgery

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Lumbar spinal stenosis has been shown to negatively impact health-related quality of life. Interspinous process decompression (IPD) is a minimally invasive procedure that utilizes a stand-alone spacer to serve as a joint extension blocker to relieve neural compression in patients with spinal stenosis. Using the 5-year results from an FDA randomized controlled trial of IPD, the quality of life in 189 patients treated with the Superion® spacer was evaluated with the SF-12. Physical and mental component summary (PCS, MCS) scores were computed preoperatively and at annual intervals. For the PCS, mean scores improved from 29.4 ± 8.1 preoperatively to 41.2 ± 12.4 at 2 years (40%) and to 43.8 ± 11.6 at 5 years (49%) (p<0.001 for both comparisons). At 2 years, 81% (103 of 128) of subjects demonstrated maintenance or improvement in PCS scores. The mean MCS score improved from 50.0 ± 12.7 preoperatively to 54.4 ± 10.6 and 54.7 ± 8.6 at 2 and 5 years, respectively (p>0.10 for both comparisons). These results demonstrate that the significant impairment in physical well-being found in patients with lumbar spinal stenosis can be ameliorated, in large part, by IPD treatment.

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“…Clinical follow-up from a US Food and Drug Administration (FDA) investigational device exemption (IDE) randomized controlled trial of the Superion device extends to 5 years of published findings. 24 Durable and clinically significant improvements have been demonstrated following spacer implantation in condition-specific impairment, leg- and back-pain severity, functional disability, and health-related quality of life. The degree of clinical improvement achieved with spacers appears to be strikingly similar to the improvement achieved with decompressive laminectomy, long considered the “gold standard” for surgical treatment of LSS.…”

Section: Introductionmentioning

confidence: 99%

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

Nunley¹,

Deer²,

Benyamin³

et al. 2018

JPR

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BackgroundLumbar 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.MethodsThis 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.ResultsAt 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.ConclusionStand-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.

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Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis

Cited by 47 publications

References 17 publications

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis

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

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