Antibiotic Impregnated Bone Graft to reduce infection in hip replacement - the ABOGRAFT trial
Phase 1
Recruiting
- Conditions
- Prosthetic 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]
- Registration Number
- CTIS2024-510921-25-00
- Lead Sponsor
- Region Oestergoetland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 850
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method