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NCT Number: NCT05169229

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Expected difficulties to complete 2-year follow-up
  • Females of child bearing potential not using contraception
  • Pregnant females
  • Nursing females

Treatment and study plan

Vancomycin + Tobramycin

Drug

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.

Other names: Treatment

Saline

Drug

As a placebo added to the allograft.

Other names: Control

Primary outcomes

  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.

    Time frame: 2 years after finalizing data collection.

    Reoperation due to infection or diagnosed PJI 2 years after index surgery.

Secondary outcomes

  1. Time to reoperation due to infection or diagnosis of PJI with any microorganism in the same hip joint within 2 years after THA.

    Time frame: All infections within 2 years after index surgery.

    Whereas the major outcome only takes into account infections that are sensitive to the antibiotic used this secondary outcomes includes all infections

  2. 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 reoperation for any reason within 2 and 5 years

  3. 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.

    Time to and cause for implant revision due to any reason within 2 and 5 years

  4. Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection

    Time frame: 2 and 5 years after finalizing data collection.

    Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection.

Other outcomes

  1. 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 frequencies of adverse events

  2. 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.

    Differences between the two experimental groups regarding the rates of revision due to aseptic loosening

Study contacts

Contact information is provided by the study sponsor or research team.

Daphne Wezenberg, PhD

CONTACT

[email protected]

0046101030000

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Region Östergötland
  • The Swedish Research Council

Registry information

Official study title

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial

Acronym: ABOGRAFT

Important dates

Study start
2022
Primary completion
2028
Study completion
2031
First posted
Dec 23, 2021
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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