Arthroplasty, Replacement, HipPhase 2ABOGRAFTNCT05169229
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
A Phase 2 study testing Vancomycin + Tobramycin and Saline in people with Arthroplasty, Replacement, Hip and Osteoarthritis, Hip, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Antibiotic Resistant Infection
- What is being tested?
- Vancomycin + Tobramycin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to Dec 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Expected difficulties to complete 2-year follow-up
- Females of child bearing potential not using contraception
- Pregnant females
- Nursing females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Universitetssjukhuset Linköping
Linköping, Region Östergotland, 58185
Jörg Schilcher, MD, PhD, Prof., 0046 101034312, jorg.schilcher@liu.se
daphne Wezenberg, PhD, 0046 793345789, daphne.wezenberg@liu.se
About this study
Official title: Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
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.
- Conditions
- Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Antibiotic Resistant Infection, Prosthetic Joint Infection
- Being tested
- Vancomycin + Tobramycin, Saline
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin + TobramycinDrug
Also called Treatment
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.
SalineDrug
Also called Control
As a placebo added to the allograft.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty. Receives: Drug: Vancomycin + Tobramycin |
| Placebo | Placebo comparator | Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after finalizing data collection.
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 2 and 5 years after finalizing data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Apr 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase II, randomized, double-blind, placebo-controlled, multicenter drug trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Region Östergötland, The Swedish Research Council
- Responsible party
- Principal investigator, Jörg Schilcher, University Hospital, Linkoeping
- Investigators
- Jörg Schilcher, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169229
- Sponsor's protocol ID
- ABOGRAFT-01
- Other IDs
- 2024-510921-25-00
- Acronym
- ABOGRAFT
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Wezenberg D, Hailer NP, Skoldenberg O, Stefansdottir A, Tsikandylakis G, Wildeman P, Karrholm J, Soderquist B, Nilsson LE, Schilcher J. Antibiotic-impregnated bone graft to prevent infection after total hip arthroplasty (ABOGRAFT): protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2026 Sep 11;16(9):e114161. doi: 10.1136/bmjopen-2025-114161.
PubMed 42731828