Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. (ABOGRAFT)

University Hospital, Linkoeping

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Arthroplasty, Replacement, Hip; Prosthetic Joint Infection; Osteoarthritis, Hip; Antibiotic Resistant Infection

Treatments: Drug: Vancomycin + Tobramycin; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05169229

ABOGRAFT-01

2021-001708-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Hip arthroplasty requiring bone graft
3. Willing to provide informed consent.
4. For women of childbearing potential; a negative pregnancy test prior to reoperation.

Exclusion criteria

1. Ongoing prosthetic joint infection
2. Known allergies and contraindications for the use of vancomycin or tobramycin
3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
4. Expected difficulties to complete 2-year follow-up
5. Females of child bearing potential not using contraception
6. Pregnant females
7. Nursing females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,100 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

Description:

Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.

Treatment:

Drug: Vancomycin + Tobramycin

Placebo

Placebo Comparator group

Description:

Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.

Treatment:

Drug: Saline