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

This trial does not accept healthy volunteers

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 surgery.

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

Design model

Parallel

Treatments tested in this trial

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.
Saline
Drug
As a placebo added to the allograft.

Treatment groups

1,100 Participants

are divided into 2 treatment groups

Group A: Treatment armExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Time frame

2 years after finalizing data collection.

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.

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.

2

Time to and cause for reoperation for any reason within 2 and 5 years

Time frame