Safety study on heat treatment of infected total hip implants
| ISRCTN | ISRCTN13670350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13670350 |
| Protocol serial number | U1111-1306-4806 |
| Sponsor | LUMC |
| Funder | Implant Preservation Devices B.V. |
- Submission date
- 03/04/2024
- Registration date
- 04/08/2026
- Last edited
- 04/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Infection occurring after joint replacement surgery is a serious problem that can happen when certain types of bacteria form a layer called biofilm around the implant. This complication can be very harmful to patients. The usual way to treat early infections after a total hip replacement surgery is called Debridement, Antibiotics, and Implant Retention (DAIR). However, this treatment doesn't always work well, and when it fails, it can lead to more health problems and even death for the patient.
A new approach called Induction Heating of metal implants and direct heating of non-metal implants (IDH) has been developed. This method involves using heat to damage the bacterial biofilm, which can kill the bacteria and weaken the biofilm. This heating process can be added to the DAIR treatment to improve its success rate, which is called i-DAIR.
The idea behind this study is to see if it's safe to use heating alongside DAIR for patients who have a post-joint replacement infection after a total hip replacement surgery. This study is specifically looking at safety aspects such as whether the implant stays in place properly, whether there's any damage to the bone caused by the heat, which can be monitored using CT scans, and overall how many negative events happen during the treatment.
Who can participate?
Patients aged 18 years or older who are scheduled for DAIR for suspected PJI after hip replacement.
What does the study involve?
Enrolled patients will receive in addition to the standard of care, heat treatment of the extraosseous parts of the implant during surgery. Patients will be followed for a duration of 1 year with CT RSA migration analyses, clinical evaluation including infection parameters < 1 week, 3 months, 6 months and 1 year.
What are the possible benefits and risks of participating?
While the patients participating in this study may not directly derive any immediate benefits, the results of the study should improve the knowledge on the safety of induction heating during DAIR which is a very promising new treatment for patients with prosthetic joint infections especially considering consistent in vitro findings of efficacy against mature bacterial biofilms, which are confirmed by other independent research groups.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As IDH is an add-on to an existing treatment (DAIR), the duration is approximately 5 additional minutes duration of the DAIR surgery. The risk of thermal damage is very low as international safety thresholds for thermal dose (16CEM43) are adhered to and acceptable thermal limits to bone are not exceeded. The potential benefit, based on invitro studies, is the higher probability of success of the DAIR procedure.
Where is the study run from?
Leiden University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
March 2024 to July 2027
Who is funding the study?
Implant Preservation Devices B.V. (Netherlands)
Who is the main contact?
vandewateringen@ipd.health
b.g.c.w.pijls@lumc.nl
Contact information
Public
Langegracht 70
Leiden
2312NV
Netherlands
| vandewateringen@ipd.health |
Scientific, Principal investigator
Leiden University Medical Center
Albinusdreef 2
Leiden
2300RC
Netherlands
 ORCID ID |
0000-0001-5351-5057 |
|---|---|
| Phone | +31 715263613 |
| b.g.c.w.pijls@lumc.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Phased prospective cohort study |
| Secondary study design | Cohort study |
| Scientific title | Induction heating heated debridement antibiotics and implant retention (i-DAIR) safety study “i-DAIR study” |
| Study acronym | i-DAIR |
| Study objectives | The hypothesis is that heating can be safely used during Debridement Antibiotics and Implant Retention (DAIR) for patients with prosthetic joint infection (PJI) after primary total hip arthroplasty (THA). |
| Ethics approval(s) |
Approved 10/03/2026, The Medical Ethics Committee Leiden The Hague Delft (Leiden University Medical Center, Albinusdreef 2, Leiden, 2333 ZA, Netherlands; +31 71 526 3241; metc-ldd@lumc.nl), ref: NL-010239 |
| Health condition(s) or problem(s) studied | Prosthetic Joint Infection (PJI) after primary total hip arthroplasty who require a DAIR procedure |
| Methodology | Enrolled patients will receive in addition to the standard of care, heat treatment of the extraosseous parts of the implant during surgery. Patients will be followed for a duration of 1 year with CT RSA migration analyses, clinical evaluation including infection parameters < 1 week, 3 months, 6 months and 1 year. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 3 months |
| Key secondary outcome measure(s) |
1. Monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 6 months and 1 year follow-up |
| Completion date | 01/07/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Age 18 years or older 2. Scheduled for DAIR for suspected PJI after primary THA 3. The patient has a primary THA of a brand/type that was tested during the ex vivo studies for having a safe heating profile for i-DAIR 4. Ability to give informed consent |
| Key exclusion criteria | 1. No informed consent 2. Pregnancy or plans for pregnancy during the study period (due to CT migration scans) 3. Medical condition precluding major surgery 4. Pacemaker 5. Hemi arthroplasties 6. DAIR for suspected PJI after revision surgery (regardless of reason) 7. One stage or two stage revision surgery for PJI instead of DAIR 8. Conversion of DAIR to one or two stage revision during the same surgical session 9. Primary THA implant is of a different type than tested during ex-vivo studies 10. Primary THA implant has not passed the safety profile during ex-vivo studies |
| Date of first enrolment | 01/12/2024 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden
2300RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
29/07/2026: Trial's existence confirmed by The Medical Ethics Committee Leiden The Hague Delft.
