Evidence map›Paper›PMID 29983583›Full record

ArticleClinicoEconomics and outcomes research : CEOR2018

Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial.

Peter Douglas Klassen, Wellington K Hsu, Frederic Martens, Jason A Inzana, Wimar A van den Brink, Michael W Groff, Claudius Thomé

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ClinicoEconomics and outcomes research : CEOR, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01283438 (A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT01283438 phase4unknown statusnot on this map

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors

TypeinterventionalSponsorIntrinsic TherapeuticsRan2010 to 2025Enrolled554ConditionsLumbar Disc HerniationArmsBarricaid, Standard of Care
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 18 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

7 authors at 7 institutions in 5 countries.

Peter Douglas KlassenDepartment of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany.
Wellington K HsuDepartment of Orthopaedic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Frederic MartensDepartment of Neurosurgery, OLV Ziekenhuis, Aalst, Belgium.
Jason A InzanaTelos Partners LLC, Denver, CO, USA, jinzana@telospartnersllc.com.
Wimar A van den BrinkNeurochirurgisch Centrum Zwolle, Zwolle, the Netherlands.
Michael W GroffNeurosurgical Spine Service, Brigham and Women's Hospital, Boston, MA, USA.
Claudius ThoméDepartment of Neurosurgery, Innsbruck Medical University, Innsbruck, Austria.
Brigham and Women's Hospital · USHealthPartners · USInnofeet · NLInnsbruck Medical University · ATNorthwestern University · USOnze Lieve Vrouwziekenhuis Hospital · BESt. Bonifatius Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLumbar discectomy patients with large annular defects are at a high risk for reherniation and reoperation, which could be mitigated through the use of an annular closure device (ACD). To identify the most effective treatment pathways for this high-risk population, it is critical to understand the clinical outcomes and socioeconomic costs among reoperated patients as well as the utility of ACD for minimizing reoperation risk.

methodsThis was a post hoc analysis of a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the safety and efficacy of an ACD. All 550 patients (both ACD treated and control) from the RCT with follow-up data through 2 years were included in this analysis (69 reoperated and 481 non-reoperated). Reoperations were defined as any revision surgery of the index level, regardless of indication. Equivalent U.S. Medicare expenditures for reoperations were estimated through cost multipliers derived from the commercially available PearlDiver database.

resultsA significantly greater number of control patients (45/278; 16%) compared to ACD patients (24/272; 9%) underwent a revision surgery at the index level within 2 years of followup (

conclusionPost-discectomy reoperation is associated with significantly increased patient morbidity, missed work, and direct treatment costs in a population at high risk for reherniation. Annular closure helped minimize this clinical and socioeconomic burden by reducing the incidence of reoperation by nearly 50% (16% control vs 9% ACD).

Indexed as

annular closure devicedirect costslumbar discectomypatient-reported outcomesreherniationreoperation

Identifiers

PMID29983583
PMCPMC6027694
OpenAlexW2810537222

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.