Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Linkoeping

About this 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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Hip arthroplasty requiring bone graft

Willing to provide informed consent.

For women of childbearing potential; a negative pregnancy test prior to reoperation.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vancomycin + Tobramycin
  • Saline

Treatment groups

1,100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Linkoeping

Lead sponsor

Region Östergötland

Collaborator

The Swedish Research Council

Collaborator