Using antibiotic-impregnated bone grafts to prevent infections in hip replacements
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
PHASE2; PHASE3 · University Hospital, Linkoeping · NCT05169229
This study is testing if using bone grafts soaked in antibiotics can help prevent infections in people getting hip replacements.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Linkoeping (other) |
| Locations | 1 site (Linköping, Region Östergotland) |
| Trial ID | NCT05169229 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of antibiotic-impregnated bone grafts to reduce the risk of periprosthetic joint infections in patients undergoing total hip replacement. The study aims to evaluate the effectiveness of combining vancomycin and tobramycin with impacted morselized bone allograft in preventing infections, particularly in complex primary and revision surgeries. Participants will be monitored for two years to assess infection rates and overall outcomes following hip arthroplasty.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require hip arthroplasty and are willing to provide informed consent.
Not a fit: Patients with ongoing prosthetic joint infections or known allergies to the study antibiotics will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections following hip replacement surgeries, improving patient outcomes and quality of life.
How similar studies have performed: Previous studies have shown success with local antibiotic delivery methods in reducing postoperative infections, making this approach promising yet still requiring further investigation.
Eligibility criteria
Show full inclusion / exclusion 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. Females of child bearing potential not using contraception 6. Pregnant females 7. Nursing females
Where this trial is running
Linköping, Region Östergotland
- Universitetssjukhuset Linköping — Linköping, Region Östergotland, Sweden (RECRUITING)
Study contacts
- Principal investigator: Jörg Schilcher, PhD — Linkoeping University
- Study coordinator: Daphne Wezenberg, PhD
- Email: daphne.wezenberg@liu.se
- Phone: 0046101030000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Antibiotic Resistant Infection, Prosthetic Joint Infection