Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. (NCT05169229) | Clinical Trial Compass
RecruitingPhase 2
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Sweden1,100 participantsStarted 2022-04-01
Plain-language summary
Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities.
The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent.
Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Hip arthroplasty requiring bone graft
. Willing to provide informed consent.
. For women of childbearing potential; a negative pregnancy test prior to surgery.
Exclusion criteria
. Ongoing prosthetic joint infection
. Known allergies and contraindications for the use of vancomycin or tobramycin
. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether antibiotic-impregnated bone graft can reduce the risk of prosthetic joint infection after hip replacement — since it's a Phase 2 study, what is currently known about its safety in humans, and how does that affect whether it might be right for me?
2The trial tracks whether patients need a reoperation due to infection within two years, specifically from bacteria sensitive to vancomycin or tobramycin — what happens if I develop an infection from a bacteria that isn't sensitive to those antibiotics, and would I still be covered under the trial's follow-up care?
3Since this study is still recruiting, am I a good candidate based on my specific diagnosis and overall health, or would standard hip replacement without the antibiotic bone graft be a more proven option for someone in my situation?
4The trial focuses on prosthetic joint infection as its main risk being measured — how common is that complication in hip replacement generally, and how does my personal risk level compare to what this trial is trying to address?
5If I enroll and am assigned to the control group rather than receiving the antibiotic-impregnated bone graft, what treatment would I actually receive, and would I be giving up access to any other infection-prevention approaches that might otherwise be used in my surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty.
Timeframe: 2 years after finalizing data collection.