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

Who is this study for? Patients with Hip Osteoarthritis, Prosthetic Joint Infection
What treatments are being studied? Vancomycin+Tobramycin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Hip arthroplasty requiring bone graft

• Willing to provide informed consent.

• For women of childbearing potential; a negative pregnancy test prior to reoperation.

Locations
Other Locations
Sweden
Universitetssjukhuset Linköping
RECRUITING
Linköping
Contact Information
Primary
Daphne Wezenberg, PhD
daphne.wezenberg@liu.se
0046101030000
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2031-12
Participants
Target number of participants: 1100
Treatments
Experimental: Treatment arm
Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.
Placebo_comparator: Placebo
Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.
Sponsors
Leads: University Hospital, Linkoeping
Collaborators: Region Östergötland, The Swedish Research Council

This content was sourced from clinicaltrials.gov