Chronic Pain Clinical Trial
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
NCT number | NCT05735574 |
Other study ID # | 307575 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | April 1, 2024 |
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.
Status | Not yet recruiting |
Enrollment | 18 |
Est. completion date | April 1, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | Medtronic |
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 N — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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