Evidence map›Paper›PMID 34103977›Full record

ArticleJournal of pain research2021

Multicenter Retrospective Review of Safety and Efficacy of a Novel Minimally Invasive Lumbar Interspinous Fusion Device.

Steven M Falowski, Vipul Mangal, Jason Pope, Anish Patel, Mark Coleman, Dan Kendall, Richard Brouillette, Michael A Fishman

Open access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Steven M FalowskiNeurosurgical Associates of Lancaster, Lancaster, PA, USA.ORCID 0000-0003-3996-087X
Vipul MangalNational Spine and Pain, National Harbor, MD, USA.
Jason PopeEvolve Restoration, Santa Rosa, CA, USA.
Anish PatelNational Spine and Pain, Frederick, MD, USA.
Mark ColemanNational Spine and Pain, Pikesville, MD, USA.
Dan KendallNational Spine and Pain, McLean, VA, USA.
Richard BrouilletteNational Spine and Pain, White Plains, MD, USA.
Michael A FishmanCenter for Interventional Pain and Spine, Lancaster, PA, USA.ORCID 0000-0002-6051-5909
International Spine, Pain & Performance · USEvolve Restorative Center · USNational Institute of Arthritis and Musculoskeletal and Skin Diseases · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSeveral treatment options exist for those with spinal stenosis, as well as degenerative changes. This series evaluates the use of an interspinous fixation (ISF) device as performed by interventional pain physicians.

methodsThis is a retrospective analysis identifying 32 patients with the diagnosis of lumbar degenerative disc disease with secondary diagnosis of lumbar spinal stenosis being treated with ISF with Aurora Spine Zip Interspinous Spacer. Serious adverse events, specifically nerve injury, hematoma, infection, and death, were analyzed quantitatively for reported complications within 90 days from the procedure. In addition, VAS was analyzed for patient reported outcomes.

resultsAdverse event rate was 0% with no incidences of reoperation, or device removal. Estimated blood loss was recorded as less than 50 cc for all patients. The preoperative pain assessment demonstrated an average pain score of 8.1 and a postoperative pain score of 2.65 equating to a percentage pain reduction of 67%.

conclusionThis case series demonstrates the success and safety of ISF being performed by interventional pain physicians in an outpatient setting. It is a valuable tool in the treatment of moderate to severe lumbar spinal stenosis and degenerative disc disease that has decreased morbidity and significant efficacy.

Indexed as

indirect decompressioninterspinous fixationinterspinous fusioninterspinous spacerlumbar degenerative disc diseaselumbar stenosisspinal fusionspinal stenosis

Identifiers

PMID34103977
PMCPMC8180294
OpenAlexW3167286695

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.