Determining Cost of Explant of Neurmodulation Device Due to Infection

NCT05735574 | Unknown

• 1 other identifier: 307575
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathic Pain; Infections; Device Related Sepsis; Chronic Pain

Keywords

Spinal Cord Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Cost of explant, intermediate care and re-implantation of device

  Cost of explant, intermediate care and re-implantation of device

  Until device re-implanted which will vary from 3 months- 1 year

Secondary Outcomes (1)

• Pathway of patients from device explantation until re-implantation of device

  up to re-implant or decision not to which will vary from 3 month- 1 year

Interventions

IPG infections OTHER

Infected IPGs

Also known as: Infected IPG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have neuromodulation devices explanted due to infection

You may qualify if:

• 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

You may not qualify if:

• Explant of a device for another reason

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Medtronic: collaborator

Related Publications (1)

• Al-Kaisy A, Royds J, Al-Kaisy O, Palmisani S, Pang D, Smith T, Padfield N, Harris S, Wesley S, Yearwood TL, Ward S. Explant rates of electrical neuromodulation devices in 1177 patients in a single center over an 11-year period. Reg Anesth Pain Med. 2020 Nov;45(11):883-890. doi: 10.1136/rapm-2020-101681. Epub 2020 Aug 26.

  PMID: 32848088 RESULT

MeSH Terms

Conditions

Neuralgia; Infections; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonathan Royds, MB MD

CONTACT

+44 20 7188 7188; jonathan.royds@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: April 1, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share