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Clinical Trials/2024-510921-25-00
2024-510921-25-00
Recruiting
Phase 2

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

Region Oestergoetland10 sites in 1 country850 target enrollmentStarted: March 19, 2024Last updated:
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Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Region Oestergoetland
Enrollment
850
Locations
10
Primary Endpoint
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
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection 2 years after hip arthroplasty, compared to controls treated with placebo impregnated bone graft.

Study Design

Allocation
Randomized
Primary Purpose
Antibiotic Impregnated Bone Graft to reduce infection in hip replacement. The ABOGRAFT trial.
Masking
Double (Investigator, Carer, Subject, Analyst)

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 18 years
  • •Hip arthroplasty requiring bone graft
  • •Willing to provide informed consent
  • •For females of childbearing potential; a negative pregnancy test prior to reoperation

Exclusion Criteria

  • •Ongoing prosthetic joint infection
  • •Known allergies and contraindications for the use of vancomycin or tobramycin
  • •Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
  • •Expected difficulties to complete 2-year follow-up
  • •Females of child bearing potential not using contraception
  • •Pregnant females
  • •Nursing females

Outcomes

Primary Outcomes

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

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 Outcomes

  • 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

Investigators

Sponsor
Region Oestergoetland
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Jörg Schilcher

Scientific

Region Oestergoetland

Study Sites (10)

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