Actively Recruiting
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
Led by University Hospital, Linkoeping · Updated on 2025-07-22
1100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Linkoeping
Lead Sponsor
R
Region Östergötland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Total hip replacement is a common and effective surgery to improve quality of life, but infections around the artificial joint can be a serious problem. This trial studies whether using antibiotic-treated bone grafts can lower infection rates after hip replacement surgery compared to bone grafts treated with a placebo. It focuses on patients undergoing elective hip arthroplasty, including complex revision surgeries, aiming to reduce infections that often require additional operations. Participants are randomly assigned to one of two groups: one receives a combination of vancomycin and tobramycin antibiotics mixed into bone graft material, while the other group receives a placebo saline solution mixed with the bone graft. These treatments are applied locally during revision hip surgeries. This is a double-blind trial, meaning neither patients nor doctors know which treatment is given. The study follows participants for at least two years after surgery to assess outcomes. Throughout the trial, researchers will monitor participants for reoperations caused by infections sensitive to the antibiotics used. They will also track reasons and timing of any reoperation or implant revision within two and five years. Participants will undergo regular follow-up visits to evaluate infection status and joint function. The study collects data on bacterial types and antibiotic resistance in any infections. This close monitoring helps assess the safety and effectiveness of the antibiotic bone graft over time.
CONDITIONS
Brief Title
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Who Can Participate
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, negative pregnancy test prior to reoperation
You will not qualify if you...
- Active prosthetic joint infection
- Known allergy or contraindication to vancomycin or tobramycin
- Mental, language, or cognitive difficulties affecting study understanding
- Expected difficulty completing 2-year follow-up
- Women of childbearing potential not using contraception
- Pregnant women
- Nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day
Participants receive a combination of vancomycin and tobramycin or saline added to bone graft during revision hip arthroplasty surgery.
1 surgery visit (in-person)
Duration - Up to 5 years
Participants are monitored for up to 5 years after surgery to assess infection and implant outcomes.
Scheduled follow-up visits over 2 and 5 years
Trial Site Locations
Total: 1 location
1
Universitetssjukhuset Linköping
Linköping, Region Östergotland, Sweden, 58185
Actively Recruiting
Research Team
D
Daphne Wezenberg, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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