Determining Cost of Explant of Neurmodulation Device Due to Infection

February 9, 2023 updated by: Guy's and St Thomas' NHS Foundation Trust

To Determine the Cost of Explant and Management of Spinal Cord Stimulation Devices Related to Implantable Pulse Generator Infection in a Single Center Specializing in Neuromodulation

Spinal cord stimulation (SCS) is a medical device inserted beside the spine to treat nerve pain. When the device becomes infected (which happens 4 % of the time) it needs to be taken out and put back in again at a later date. So far we are unsure of how much this process costs. I am going to analyse data collected on a database of all devices taken out due to infection and calculate an average cost of taking them out, the intermediate care and putting them back in again in our hospital only. This will enable us to understand how much this process costs and if there are any methods of reducing the chance of infection in the future; we will be able to work out how much the NHS should pay for these products based on this data. This will be done in Guys and St Thomas's from a database in the chronic pain research department in patients who had their device taken out due to infection. It will take 6 months and will all be retrospective. Additional details may be collected from patients electronic records where needed. These will be collected by a member of the direct care team and pseudonymised prior to adding to the research data set.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Design: Retrospective chart and electronic record review of all explants due to infection with cost analysis up to re-implantation.

Methods:

Based on a database there are approximately N=18-20 infections over 7 years with adequate data to determine the overall cost of explant due to infection. The data to be collected will include: hospital admission, surgical time, blood tests, swabs, antibiotic therapy, additional outpatient visits, cost of re-implantation. These can be collected from electronic patient records (EPR). The cost of individual patient admissions will be obtained from the account services at Guys and St Thomas's and sent in a password protected database.

The site of infection will also be recorded and this can be obtained from the operative note. A study by Hayek and colleagues have indicated only 10% of infections are at the lead site and the majority are at the IPG site. Another review by Follet and colleagues have indicated only 54% of infections are at the IPG site, 17% at the lead site and the others not clearly determined. For this reason, there will need to be a range of costs based on the confirmed and the indeterminate sites of infection. The main focus of this paper will be on IPG infections since TYRX is only used at the IPG site.

Economic metrics will also be taken into consideration which have been described in the UK as some patients for technical reasons cannot be re-implanted with SCS systems after infection. The cost effectiveness of this therapy is essentially lost in these patients forever. The time proceeding to re-implantation can also be reviewed and incorporated. There was an NIHR review of cost analysis of these systems published in the UK that can be used for this. Specifically the cost of SCS and conventional medical management (CMM) is £3440 in year one of these devices and CMM alone is £6936.

Study Type

Observational

Enrollment (Anticipated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that have neuromodulation devices explanted due to infection

Description

Inclusion Criteria:

  • Any patient who had an explant of a neuromodulation device due to infection between 2013-2020 in our centre.
  • Any patient who had as suspected explant of a spinal cord stimulator due to infection

Exclusion Criteria:

• Explant of a device for another reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of explant, intermediate care and re-implantation of device
Time Frame: Until device re-implanted which will vary from 3 months- 1 year
Cost of explant, intermediate care and re-implantation of device
Until device re-implanted which will vary from 3 months- 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathway of patients from device explantation until re-implantation of device
Time Frame: up to re-implant or decision not to which will vary from 3 month- 1 year
up to re-implant or decision not to which will vary from 3 month- 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There will only be a report to the financial sponsor in anonymous format

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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