Universitetssjukhuset Linköping
Linköping, Region Östergotland, 58185, Sweden
Location status: Recruiting
Location contact
Jörg Schilcher, MD, PhD, Prof.
CONTACT
daphne Wezenberg, PhD
CONTACT
NCT Number: NCT05169229
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Linköping, Region Östergotland, 58185, Sweden
Location status: Recruiting
Jörg Schilcher, MD, PhD, Prof.
CONTACT
daphne Wezenberg, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Treatment
As a placebo added to the allograft.
Other names: Control
Time frame: 2 years after finalizing data collection.
Reoperation due to infection or diagnosed PJI 2 years after index surgery.
Time frame: All infections within 2 years after index surgery.
Whereas the major outcome only takes into account infections that are sensitive to the antibiotic used this secondary outcomes includes all infections
Time frame: 2 and 5 years after finalizing data collection.
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.
Differences between the two experimental groups regarding the frequencies of adverse events
Time frame: 2 and 5 years after finalizing data collection.
Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
Contact information is provided by the study sponsor or research team.
University Hospital, Linkoeping
Other
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
Acronym: ABOGRAFT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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