Prosthetic Joint Infection (PJI) after primary total hip arthroplasty who require a DAIR procedure Surgery
Conditions
Interventions
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 R
Sponsors
LUMC
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 6 months and 1 year follow-up 2. Determine the fixation of the femoral stem and acetabular cup after i-DAIR procedure measured using CT radiostereometric analysis (RSA) 3. Monitor these patients for any unexpected side effects during the first year post-operative | — |
Countries
Netherlands
Contacts
Public ContactRichard van de Wateringen
Outcome results
None listed