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Study on Reducing Prosthetic Joint Infection in Hip Replacement Patients Using Vancomycin, Tobramycin, and Saline-Infused Bone Graft

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Prosthetic Joint Infection, which can occur after a hip replacement surgery. The trial is called the ABOGRAFT trial and aims to find out if using an antibiotic impregnated bone graft can reduce the risk of infection two years after hip replacement surgery. A bone graft is a procedure where bone material is used to help repair or replace damaged bones. In this study, the bone graft is treated with antibiotics to see if it helps prevent infections.

The antibiotics being tested in this study are Vancomycin and Tobramycin. These are medicines used to treat infections caused by bacteria. The study will compare the effects of the antibiotic-treated bone graft with a placebo-treated bone graft. A placebo is a substance with no active medication, used to compare the effects of the actual treatment. The study will observe if there is a difference in the rate of infections between the two groups over a period of two years.

Participants in the study will receive either the antibiotic-treated bone graft or the placebo-treated bone graft during their hip replacement surgery. The study will monitor the participants for any signs of infection or need for additional surgery in the same hip joint within two years. It will also look at the time and reasons for any further surgeries or implant revisions within two to five years. The study aims to provide valuable information on whether the antibiotic-treated bone graft can effectively reduce the risk of infection after hip replacement surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be 18 years or older, require a hip replacement with a bone graft, and provide informed consent. Women of childbearing potential must have a negative pregnancy test before reoperation.

  2. Step 2

    Initial treatment

    Participants undergo hip arthroplasty, a surgical procedure to replace the hip joint. During the surgery, a bone graft is used. The bone graft is either impregnated with antibiotics or a placebo, depending on the group assignment.

  3. Step 3

    Medication administration

    The antibiotics used in the study are vancomycin and tobramycin. These are administered directly into the joint area during surgery. The method of administration is called intraarticular use, meaning the medication is delivered directly into the joint space.

  4. Step 4

    Post-surgery monitoring

    After surgery, participants are monitored for any signs of infection or complications. The primary goal is to observe whether the antibiotic-impregnated bone graft reduces the risk of infection within two years after the hip replacement.

  5. Step 5

    Follow-up assessments

    Participants will have follow-up assessments to check for any reoperation due to infection or other reasons. These assessments occur within two and five years after the initial surgery. The type of bacteria and their resistance to antibiotics will also be evaluated if infections occur.

  6. Step 6

    Study completion

    The study is expected to conclude by April 1, 2031. The final analysis will compare the outcomes between the group receiving the antibiotic-impregnated bone graft and the placebo group, focusing on infection rates and any adverse events.

Who can join the trial?

4 criteria

  • Must be **18 years old** or older.
  • Must need a **hip replacement surgery** that requires a bone graft. A bone graft is a procedure where new bone material is added to help repair or replace damaged bone.
  • Must be willing to **give permission** to participate in the study. This means you agree to join the study after understanding what it involves.
  • For women who can have children, a **negative pregnancy test** is required before the surgery. This means the test must show that you are not pregnant.

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have conditions or factors that the study has not specifically mentioned as being included.
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Investigated drugs

Antibiotic Impregnated Bone Graft (AIBG) is a special type of bone graft used in hip replacement surgeries. It is designed to help reduce the risk of infection by slowly releasing antibiotics directly at the site where the bone graft is placed. This helps to prevent bacteria from growing and causing an infection after the surgery. The goal of using this graft is to improve the healing process and ensure a better outcome for patients undergoing hip replacement.

What is already known about the treatment

Antibiotic Impregnated Bone Graft (AIBG) – This medication is administered directly to the surgical site during hip replacement surgery. It is currently being studied in clinical trials to assess its effectiveness in reducing infections associated with prosthetic joints, specifically in hip arthroplasty. The main therapeutic indication is to prevent prosthetic joint infections. The mechanism of action involves the local release of antibiotics from the bone graft, which helps to eliminate bacteria and prevent infection. It is classified as an antibiotic delivery system used in orthopedic procedures.

Investigated diseases

Prosthetic Joint Infection – This condition occurs when bacteria or other microorganisms infect the area around a joint prosthesis, such as a hip or knee replacement. It typically develops when bacteria enter the body during surgery or through the bloodstream. Symptoms may include pain, swelling, and redness around the joint, as well as fever and fatigue. The infection can lead to loosening of the prosthetic joint, causing instability and difficulty in movement. Over time, the infection may cause damage to the surrounding bone and tissue. If not managed, it can result in the need for additional surgeries to remove or replace the prosthetic joint.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510921-25-00Estimated enrolment1 400 patientsSponsorRegion Oestergoetland

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