Prosthetic Joint Infection implant infection
Conditions
Interventions
IPD induction heater: IDH of the extra-osseous metal (neck / taper) of the femoral stem and direct heating of the acetabular cup (cemented) or inlay (uncemented). The target temperature is between 60
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 18 years or olderScheduled for DAIR for suspected PJI after primary THAThe 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*Ability to give informed consent
Exclusion criteria
Exclusion criteria: No informed consentPregnancy or plans for pregnancy during the study period (due to CT migration scans)Medical condition precluding major surgeryPacemakerHemi arthroplastiesDAIR for suspected PJI after revision surgery (regardless of reason)One stage or two stage revision surgery for PJI instead of DAIRConversion of DAIR to one or two stage revision during the same surgical sessionPrimary THA implant is of a different type than tested during ex-vivo studiesPrimary THA implant has not passed the safety profile during ex-vivo studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are:1) to monitor the bone-implant interface for possible heat induced osteolysis/necrosis after IDH using CT at 6 months and 1 year follow-up2) to determine the fixation of the femoral stem and acetabular cup after i-DAIR procedure measured using CT radiostereometric analysis (RSA).3) to monitor these patients for any unexpected side effects during the first year post-operatively4) to use the preliminary data on efficacy to guide sample size calculations for the multicentre randomized trial for efficacy. | — |
Countries
Netherlands
Contacts
Public ContactB.G.C.W. Pijls
Leids Universitair Medisch Centrum
Outcome results
None listed