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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Dalarna	Falun	Sweden
Region Skane Hassleholm Hospital	Hassleholm	Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen	Kalmar	Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Vononycnavn Snwiqmm Rhvgzn Ktypqv Lrkg	Vastervik	Sweden
Lgtbcbfpui I Maphpr Rsypbf Ocolgtqlblhm	Motala	Sweden
Rmcyif Sezic Lajtjmfuwx Tnnwhkjbxa	Trelleborg	Sweden
Uyzafgq Uyqljfnjml Hhcwswqf	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	18.03.2022

Trial locations

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.

Investigated diseases:

Medical device site joint infection

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 ID:

2024-510921-25-00

NCT ID:

NCT05169229

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?