Antibiotic Impregnated Bone Graft to Reduce Infection in Revision Hip Replacement.
Status:
Not yet recruiting
Trial end date:
2031-12-01
Target enrollment:
Participant gender:
Summary
Total hip replacement is the most successful treatment modern healthcare can offer patients
to regain quality of life. Periprosthetic joint infection (PJI) is the most common and
devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR
(first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis)
will become infected. The introduction of local antibiotics blended into bone cement has led
to a reduction in postoperative infection in primary THR by half. Unfortunately, in revision
THR antibiotic impregnated bone cement in relevant quantities can seldomly be used.
The number of revision surgeries of the hip is projected to increase dramatically. Therefore,
the need for a feasible infection prophylaxis applicable for revision THR is urgent.
Impacted morselized bone allograft is often used in revision THR to fill bone defects.
Morselized allograft has been used as a carrier for local antibiotic treatment in multiple
pilot studies and appears to be an attractive and effective treatment option, both for
already infected joints and as a prophylactic measure in high-risk patients (e.g. THR
revision surgeries). Nonetheless, a pivotal trial to support its use in revision THR is
lacking. The aim of this pragmatic randomized controlled double blinded drug trial is 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. Patients scheduled for elective revision THR will be randomized to receive AIBG or a
placebo impregnated bone graft. The primary outcome variable will be the number of
re-operations due to infections 2 years postoperative.