Study of Antibiotic-Impregnated Bone Graft to Lower Infection Risk After Hip Replacement Surgery

What this Trial Is About

Researchers are evaluating whether antibiotic impregnated bone graft AIBG can reduce the risk of infection after total hip replacement THR, a common surgery to restore quality of life. Periprosthetic joint infection PJI is a serious complication affecting a small percentage of patients after primary or revision THR. Because the number of these surgeries is expected to rise, new methods to prevent infections, especially in complex cases where antibiotic-loaded bone cement is insufficient, are urgently needed. The study compares two groups of patients undergoing elective THR with bone grafts one group receives a combination of vancomycin and tobramycin antibiotics mixed with allograft bone, while the other group receives a placebo bone graft treated with saline. The treatment is applied locally during revision surgery. This randomized, double-blind trial aims to determine if the antibiotic-treated graft reduces infections requiring reoperation within two years after surgery. Participants will be monitored for at least two years after their hip replacement. Researchers will track the time to reoperation due to infection with bacteria sensitive to the antibiotics used, as well as other infection-related measures. The study involves clinical follow-up to assess infections and implant revisions, with safety and effectiveness monitored throughout the trial period, which continues until 2031.

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.