A Phase 2 interventional study of Vancomycin + Tobramycin and Saline in Arthroplasty, Replacement, Hip, Osteoarthritis, Hip and Antibiotic Resistant Infection, sponsored by University Hospital, Linkoeping. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University Hospital, Linkoeping · Phase 2, Interventional, and Treatment
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →University Hospital, Linkoeping is the lead sponsor of 119 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.
Drug: Vancomycin + Tobramycin
Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.
Drug: Saline
Drug pages: Vancomycin · Tobramycin
1 g vancomycin (powder) diluted in 8 ml tobramycin (40 -80mg/ml). Added to the prepared allograft before the allograft is used during the revision surgery.
Also known as: Treatment
As a placebo added to the allograft.
Also known as: Control
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.
Reoperation due to infection or diagnosed PJI 2 years after index surgery.
Time frame: 2 years after finalizing data collection.
Time to reoperation due to infection or diagnosis of PJI with any microorganism in the same hip joint within 2 years after THA.
Whereas the major outcome only takes into account infections that are sensitive to the antibiotic used this secondary outcomes includes all infections
Time frame: All infections within 2 years after index surgery.
Time to and cause for reoperation for any reason within 2 and 5 years
Time to and cause for reoperation for any reason within 2 and 5 years
Time frame: 2 and 5 years after finalizing data collection.
Time to and cause for implant revision due to any reason within 2 and 5 years
Time to and cause for implant revision due to any reason within 2 and 5 years
Time frame: 2 and 5 years after finalizing data collection.
Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection
Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection.
Time frame: 2 and 5 years after finalizing data collection.
Differences between the two experimental groups regarding the frequencies of adverse events
Differences between the two experimental groups regarding the frequencies of adverse events
Time frame: 2 and 5 years after finalizing data collection.
Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
Time frame: 2 and 5 years after finalizing data collection.
Plan to share: Yes — De-identified individual participant data (IPD), including the data dictionary, underlying the results reported in this study on antibiotic-impregnated bone grafts in hip arthroplasty (ABOGRAFT) will be made available upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning immediately following publication of the main results article and ending 25 years thereafter, consistent with the retention period for clinical trial data.
Access criteria: Access will be granted to qualified researchers for prespecified scientific purposes. Sharing is conditional on: (i) approval of the proposed analysis by the study sponsor and, where legally required, approval of the secondary use by the Swedish Ethical Review Authority (Etikprövningsmyndigheten); (ii) a signed data sharing and data processing agreement outlining the terms of use; and (iii) compliance with the GDPR and applicable Swedish law, including data protection, ethical review, and secrecy provisions. The agreement prohibits any attempt at re-identification and any further sharing of the data. Transfer of personal data outside the EU/EEA will occur only where permitted under GDPR. Requests for access can be submitted to the study sponsor."
Data sharing details ↗ · euclinicaltrials.eu
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Started Apr 2022 (actual). Primary completion is estimated for Dec 2028, 80 months after the start.
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Studies of the drugs tested here: Vancomycin · Tobramycin
University Hospital, Linkoeping →