Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vancomycin + Tobramycin, Saline.
- Who it may be relevant to
- Registry conditions: Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Antibiotic Resistant Infection, Prosthetic Joint Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
Overview
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.
Interventions
- Drug Vancomycin + Tobramycin
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. - Drug Saline
As a placebo added to the allograft.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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.]
- 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 implant revision due to any reason within 2 and 5 years [Time frame: 2 and 5 years after finalizing data collection.]
- Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection [Time frame: 2 and 5 years after finalizing data collection.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Universitetssjukhuset Linköping — Linköping
Identifiers
NCT: NCT05169229 · ABOGRAFT-01 · 2024-510921-25-00