ABOGRAFT study - Antibiotic-impregnated bone graft to reduce infection in hip replacement surgery

Purpose and aims: Our overarching goal is to reduce the risk of the most-dreaded post-operative complication of total hip replacement (THR) – prosthetic joint infection (PJI).

This project involves a nationwide, randomized, placebo-controlled, double-blinded clinical drug trial to test the hypothesis that antibiotic-impregnated bone graft (AIBG) reduces the risk for PJI in THR with bone graft.Survey of the field: The administration of local antibiotics as a complement to systemic antibiotic treatment has become popular in complex THR.

The advantage over standard systemic treatment is that high local concentrations of antibiotics can be achieved that inhibit perioperative colonization of the implant, thereby avoiding systemic toxicity and development of antibiotic resistance.

However, to support the clinical use of AIBG a pivotal trial is needed.Organization, time plan and methods: Within 2-years, we will establish a nationwide study group (orthopedic surgeons, infection specialists, microbiologists and patient representatives) and analyze results from a pilot study to facilitate implementation of the full study.

All hospitals using bone graft will be invited to participate.Patients: THR with bone graftIntervention: AIBGControl: SalineOutcome: risk of PJIThe exact dosing of the antibiotics and serum levels (safety assessment) will be determined during Year 1.Importance: To test if AIBG can reduce the risk for PJI in THR and avoiding development of antibiotic resistance.