Patients scheduled for any type of reoperation of a pre-existing hip arthroplasty requiring bone grafting
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Age = 18 years * Hip arthroplasty requiring reoperation or revision with bone graft * Willing to provide informed consent. * For women of childbearing potential; a negative pregnancy test prior to reoperation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 960
Exclusion criteria
Exclusion criteria: * Patients with prosthetic joint infection as the reason for the reoperation * Known allergies and contraindications for the use of vancomycin or tobramycin * Mental inability, reluctance or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation * Expected difficulties to complete 2-year follow-up * Women of child bearing potential not using contraception * Pregnant women * Nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after revision hip arthroplasty, compared to controls treated with placebo impregnated bone graft. ;Secondary Objective: To investigate differences between the two experimental groups in: * time and cause for reoperation for any reason within 2 and 5 years * time and cause for implant revision due to any reason within 2 and 5 years * the type of microbe and antibiotic resistance pattern for cases complicated with post-operative infection. Safety objective To evaluate the safety of using antibiotic impregnated bone graft (AIBG) as infection prophylaxis in revision hip arthroplasty. ;Primary end point(s): Reoperation due to infection with bacteria that are sensitive to either vancomycin or tobramycin in the same hip joint within two years after revision hip arthroplasty. ;Timepoint(s) of evaluation of this end point: two years after revision hip arthroplasty. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Time and cause for reoperation for any reason within 2 and 5 years * Time and cause for implant revision due to any reason within 2 and 5 years * Type of microbe and antibiotic resistance pattern for cases complicated with post-operative infection. Primary and secondary outcome data will be obtained with 2 complementary methods: from the SHAR and the medical charts at each study site. Type of microbe and antibiotic resistance pattern will be acquired through review of medical charts and reported laboratory results. Safety outcomes * Differences between the two experimental groups regarding the frequencies of adverse events. * Differences between the two experimental groups regarding the rates of revision due to aseptic loosening. We will not investigate osseointegration directly, but instead look at differences in the rates of revision due to aseptic loosening through review of the medical chart and included radiographs and through revisions reported to the Swedish Hip Arthroplasty Register after 2 and 5 years.;Timepoint(s) of evaluation of this end point: two years after revision hip arthroplasty, and five years after revision hip arthroplasty | — |
Countries
Sweden
Contacts
Public ContactJörg Schilcher
Region Östergötland
Outcome results
None listed