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.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities.

The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement 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 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 hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective 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 and PJI diagnoses 2 years postoperative.

Inclusion Criteria:

1. Age ≥ 18 years
2. Hip arthroplasty requiring bone graft
3. Willing to provide informed consent.
4. For women of childbearing potential; a negative pregnancy test prior to surgery.

Exclusion Criteria:

1. Ongoing prosthetic joint infection
2. Known allergies and contraindications for the use of vancomycin or tobramycin
3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
4. Expected difficulties to complete 2-year follow-up
5. Females of child bearing potential not using contraception
6. Pregnant females
7. Nursing females

De-identified individual participant data (IPD), including the data dictionary, underlying the results reported in this study on antibiotic-impregnated bone grafts in hip arthroplasty (ABOGRAFT) will be made available upon reasonable request.

Beginning immediately following publication of the main results article and ending 25 years thereafter, consistent with the retention period for clinical trial data.

Access will be granted to qualified researchers for prespecified scientific purposes. Sharing is conditional on: (i) approval of the proposed analysis by the study sponsor and, where legally required, approval of the secondary use by the Swedish Ethical Review Authority (Etikprövningsmyndigheten); (ii) a signed data sharing and data processing agreement outlining the terms of use; and (iii) compliance with the GDPR and applicable Swedish law, including data protection, ethical review, and secrecy provisions. The agreement prohibits any attempt at re-identification and any further sharing of the data. Transfer of personal data outside the EU/EEA will occur only where permitted under GDPR.

Requests for access can be submitted to the study sponsor."

Double-blinded