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Antibiotic Impregnated Bone Graft to reduce infection in hip replacement - the ABOGRAFT trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510921-25-00
Enrollment
1100
Registered
2024-03-19
Start date
2022-03-18
Completion date
Unknown
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection

Brief summary

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

Detailed description

Time and cause for reoperation for any reason within 2 and 5 years, Time and cause for implant revision due to any reason within 2 and 5 years, Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection, Differences between the two experimental groups regarding the frequencies of adverse events, Differences between the two experimental groups regarding the rates of revision due to aseptic loosening

Interventions

DRUGSALINE
DRUGTOBRAMYCIN
DRUGVANCOMYCIN

Sponsors

Region Oestergoetland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Time and cause for reoperation for any reason within 2 and 5 years, Time and cause for implant revision due to any reason within 2 and 5 years, Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection, Differences between the two experimental groups regarding the frequencies of adverse events, Differences between the two experimental groups regarding the rates of revision due to aseptic loosening

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026