Evidence map›Paper›PMID 27730704›Full record

ArticleNeuromodulation : journal of the International Neuromodulation Society2016

Intrathecal Drug Delivery Systems (IDDS): The Implantable Systems Performance Registry (ISPR).

Peter E Konrad, John M Huffman, Lisa M Stearns, Robert J Plunkett, Eric J Grigsby, E K Stromberg, Mollie P Roediger, Michelle D Wells, Todd W Weaver

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuromodulation : journal of the International Neuromodulation Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

NCT03876158 phase4withdrawnnot on this mapstarted 2019, after this paper: background citation

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)

TypeinterventionalSponsorRush University Medical CenterRan2019 to 2022Enrolled0ConditionsChronic Pain, Intractable Pain, Back PainArmsPrometra II Programmable Pump system(Flowonix Medical)
NCT04312685 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center Study

TypeinterventionalSponsorBux, Anjum, MDRan2020 to 2023Enrolled120ConditionsPain, Pain, Chronic, Pain, Intractable, Pain, BackArmsPrometra II Programmable Pump system - Flowonix Medical
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry.Neuromodulation : journal of the International Neuromodulation Society · 2021
    Article
  9. Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry.Neuromodulation : journal of the International Neuromodulation Society · 2020
    Article
  10. Article
  11. Article
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

9 authors.

Peter E KonradVanderbilt University Medical Center, Nashville, TN, USA.
John M HuffmanHoly Cross Hospital, Silver Spring, MD, USA.
Lisa M StearnsCenter for Pain and Supportive Care, Scottsdale, AZ, USA.
Robert J PlunkettUniversity at Buffalo, Buffalo, NY, USA.
Eric J GrigsbyNapa Pain Institute, Napa, CA, USA.
E K StrombergMedtronic, plc, Minneapolis, MN, USA.
Mollie P RoedigerMedtronic, plc, Minneapolis, MN, USA.
Michelle D WellsMedtronic, plc, Minneapolis, MN, USA.
Todd W WeaverMedtronic, plc, Minneapolis, MN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe ISPR was initially created to monitor the product performance of Medtronic implanted intrathecal drug infusion and spinal cord systems available in the United States. MATERIALS AND

methodsData were collected from 50 representative sites implanting and following patients with intrathecal drug delivery systems across the United States between August 7, 2003 and January 31, 2014. Device performance over time was estimated using life table survival methods.

resultsOf the 6093 patients enrolled in the ISPR, 3405 (55.9%) were female and 2675 (43.9%) were male, and 13 (0.2%) did not provide gender data. The average age at enrollment was 52.9 years (SD =17.6 years) and average follow-up time was 29.6 months. Currently, the estimates of device survival from pump-related events exceed 90% for all pump models across the applicable follow-up time points. The majority of product performance events were catheter-related. At 5 years of follow-up, all applicable catheter models, with the exception of revised not as designed or grafted not as designed catheters, had greater than 81% survival from catheter-related events.

conclusionsThe ISPR is designed to serve as an ongoing source of system and device-related information with a focus on "real-world" safety and product performance. ISPR data continue to be used to guide future product development efforts aimed at improving product reliability and quality.

Indexed as

Infusion Pumps, ImplantableInjections, SpinalAdultAgedAnalgesicsFemaleHumansLongitudinal StudiesMaleMiddle AgedMuscle SpasticityRegistriesRetrospective StudiesSurvival AnalysisTreatment OutcomeUnited StatesAnalgesicsintrathecal drug deliveryneuromodulationpainregistryspasticity

Identifiers

PMID27730704
PMCPMC5157772

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.