Analysis of Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection: a Microdialysis Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bonn

About this trial

This study aims to use the technique of microdialysis to analyse the intraarticular space of the hip joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing cement spacer over the entire period of the first hospitalization (usually 14 days) to closely monitor pharmacological and immunological aspects. In detail, antibiotic concentrations in the joint cavity and systemic circulation will be assessed according to reinfection rates, infection-free survival and fucntional outcome over a 12-month folluw-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

clinical indication for two-stage revision of hip PJI

approval for surgery by the orthopedic and anesthesiologic department

being over 18 years of age

written, informed consent after detailed patient information about the study protocol and possible study dependent risks

Disqualifiers

- known allergies to antibiotics gentamicin and vancomycin used within the spacer

Trial population

30 patients over 18 years of age presenting with PJI after total hip arthroplasty and indication for prosthesis explantation and temporary spacer implantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Patients presenting with an infected hip prosthesis

Trial outcomes

Primary outcomes

1

Intraarticular concentrations of local antibiotics

Microdialysis will help to generate intraarticular hip joint samples after removal of an infectes prosthesis and spacer implantation. These samples will be analysed for spacer eluted antibiotics.

Time frame
Pre-Surgery (prothesis removal), during 14 days of hospitalization as well as pre-surgery of the reimplantation (approx. six weeks after the first surgery)

Secondary outcomes

1

Comparison intraarticular antibiotic concentrations to venous blood concentrations

Antibiotic concentrations measured in intraarticular samples generated by microdialysis will be compared to venous blood serum concentrations

Time frame
Pre-Surgery (removal of the prothesis), during hospitalization of 14 days and before reimplantation of the prothesis.

Other outcomes

1

Correlation between infection free survival and antibiotic concentrations

Analyzed concentrations of local and systemic antibiotic concentrations will be correlated with infection free survival within the follow up (infection free survival: successfull wound healing, no signs of lossening within X-rays, no increase of inflammatory markers).

Time frame
Preoperatively, during hospitalisation, preoperatively before the second surgery and at follow up time points (6 weeks, 3 months, 6 months, 12 months).

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