Clinical trial NCT05169229: Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Official title: Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. the ABOGRAFT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Arthroplasty, Replacement, Hip
Osteoarthritis, Hip
Antibiotic Resistant Infection
Prosthetic Joint Infection
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Region Östergötland
name: The Swedish Research Council
First posted: 2021-12-23
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, phase II, randomized, double-blind, placebo-controlled, multicenter drug trial.
Primary purpose: TREATMENT

Brief summary: 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: 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. Women of child bearing potential not using contraception
6. Pregnant women
7. Nursing women

Primary outcomes:
measure: 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.
timeFrame: 2 years after finalizing data collection.
Secondary outcomes:
measure: Time and cause for reoperation for any reason within 2 and 5 years
timeFrame: 2 and 5 years after finalizing data collection.
measure: Time and cause for implant revision due to any reason within 2 and 5 years
timeFrame: 2 and 5 years after finalizing data collection.
measure: Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection
timeFrame: 2 and 5 years after finalizing data collection.
Other outcomes:
measure: Differences between the two experimental groups regarding the frequencies of adverse events
timeFrame: 2 and 5 years after finalizing data collection.
measure: Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
timeFrame: 2 and 5 years after finalizing data collection.
Locations:
city: Linköping
country: Sweden
facility: Universitetssjukhuset Linköping
state: Region Östergotland
Study officials:
affiliation: Linkoeping University
name: Jörg Schilcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: