CTIS2024-510921-25-00
Recruiting
Phase 1
Antibiotic Impregnated Bone Graft to reduce infection in hip replacement - the ABOGRAFT trial
Region Oestergoetland0 sites850 target enrollmentMarch 8, 2024
ConditionsProsthetic Joint InfectionTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]Therapeutic area: Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prosthetic Joint Infection
- Sponsor
- Region Oestergoetland
- Enrollment
- 850
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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, Women of child bearing potential not using contraception, Pregnant women, Nursing women
Outcomes
Primary Outcomes
Not specified
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