What is vancomycin and tobramycin studying for hip replacement infection?

This study is evaluating whether bone grafts treated with the antibiotics vancomycin and tobramycin can reduce infections after hip replacement surgery. Researchers aim to find if this local antibiotic treatment lowers the risk of needing reoperation due to infection, which is a serious complication. The University Hospital, Linkoeping is sponsoring this research.

Who may be eligible for this hip replacement clinical trial?

Adults aged 18 or older who need a hip replacement involving bone grafting may be eligible. Participants should not have ongoing joint infections or allergies to the study antibiotics. Women of childbearing potential must have a negative pregnancy test and use contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this hip replacement clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05169229

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

Led by University Hospital, Linkoeping · Updated on 2026-07-10

1100

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Scheduled for hip arthroplasty requiring bone graft
Willing to provide informed consent
For women of childbearing potential, a negative pregnancy test prior to surgery

You will not qualify if you...

Ongoing prosthetic joint infection
Known allergies or contraindications to vancomycin or tobramycin
Mental inability, reluctance, or language difficulties making study participation understanding difficult
Expected difficulties completing 2-year follow-up
Females of childbearing potential not using contraception
Pregnant females
Nursing females

Research Team

Daphne Wezenberg, PhD

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