Neuropathic PainNCT05735574
Determining Cost of Explant of Neurmodulation Device Due to Infection
An observational study of Neuropathic Pain and Infections, run by Guy's and St Thomas' NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Infections, Device Related Sepsis
- What is being tested?
- IPG infections
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients that have neuromodulation devices explanted due to infection
Who may be able to join
- 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
Who cannot join
- Explant of a device for another reason
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuropathic Pain, Infections, Device Related Sepsis, Chronic Pain
- Being tested
- IPG infections
- Keywords
- Spinal Cord Stimulation, Neuromodulation
- Medical subject headings
- Neuralgia, Infections, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG infectionsOther
Also called Infected IPG
Infected IPGs
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of explant, intermediate care and re-implantation of device
Cost of explant, intermediate care and re-implantation of device
Measured: 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
Measured: up to re-implant or decision not to which will vary from 3 month- 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735574
- Sponsor's protocol ID
- 307575
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will only be a report to the financial sponsor in anonymous format
Publications
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.
PubMed 32848088
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05735574
- Acronym / sponsor ID
- 307575
- Conditions
- Neuropathic Pain, Infections, Device Related Sepsis, Chronic Pain
- Keywords
- Spinal Cord Stimulation, Neuromodulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that have neuromodulation devices explanted due to infection
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Explant of a device for another reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG infectionsAlso: Infected IPGInfected IPGs | Other | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Results publication: PubMed 32848088Al-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.
- Individual participant dataSharing planned: No. There will only be a report to the financial sponsor in anonymous format
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Infections, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Royds, MB MD (+44 20 7188 7188 ext. switch, jonathan.royds@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of explant, intermediate care and re-implantation of device (time frame: Until device re-implanted which will vary from 3 months- 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.