NCT05169229: ABOGRAFT

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

Recruiting now Phase 2/Phase 3 Last updated 17 July 2025

What this trial tests

Phase 2/Phase 3 trial testing Vancomycin + Tobramycin in Arthroplasty, Replacement, Hip in 1,100 participants. Currently enrolling.

Timeline

1 April 2022

Primary endpoint
1 December 2028

1 December 2031

Quick facts

Lead sponsor	University Hospital, Linkoeping
Phase	Phase 2/Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,100
Start date	1 April 2022
Primary completion	1 December 2028
Estimated completion	1 December 2031
Sites	1 location across Sweden

Drugs / interventions tested

• Vancomycin + Tobramycin — full drug profile →
• Saline

Conditions studied

• Arthroplasty, Replacement, Hip — all drugs for Arthroplasty, Replacement, Hip →
• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →
• Antibiotic Resistant Infection — all drugs for Antibiotic Resistant Infection →
• Prosthetic Joint Infection — all drugs for Prosthetic Joint Infection →

Sponsor

University Hospital, Linkoeping

Who can join

18 and older, any sex, with Arthroplasty, Replacement, Hip or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 of revision surgery.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.