Status:
RECRUITING
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Lead Sponsor:
University Hospital, Linkoeping
Collaborating Sponsors:
Region Östergötland
The Swedish Research Council
Conditions:
Arthroplasty, Replacement, Hip
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complicat...
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
- Females of child bearing potential not using contraception
- Pregnant females
- Nursing females
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05169229
Start Date
April 1 2022
End Date
December 1 2031
Last Update
July 22 2025
Active Locations (1)
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1
Universitetssjukhuset Linköping
Linköping, Region Östergotland, Sweden, 58185