Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Launched by UNIVERSITY HOSPITAL, LINKOEPING · Dec 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether using an antibiotic-treated bone graft can help reduce the risk of infections after hip replacement surgery. Infections are a serious complication that can occur after such procedures, and while some methods have been effective, there's a need for better options, especially for patients undergoing complex or revision surgeries. In this trial, patients who are scheduled for hip replacement and need a bone graft will be randomly assigned to receive either the antibiotic-impregnated graft or a placebo (an inactive treatment). The main goal is to see how many patients experience infections requiring additional surgeries over a two-year period.

To be eligible for this study, participants must be at least 18 years old and require a bone graft for their hip surgery. They must also be willing to give their consent and, for women who can become pregnant, have a negative pregnancy test before the surgery. Those with current infections, specific allergies to certain antibiotics, or other factors that could complicate their participation will not be included. Participants can expect regular follow-ups over two years to monitor their recovery and any potential complications. This trial aims to provide valuable information that could help improve care for future hip replacement patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Hip arthroplasty requiring bone graft
• • 3. Willing to provide informed consent.
• • 4. For women of childbearing potential; a negative pregnancy test prior to reoperation.
• Exclusion Criteria:
• • 1. Ongoing prosthetic joint infection
• • 2. Known allergies and contraindications for the use of vancomycin or tobramycin
• • 3. Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
• • 4. Expected difficulties to complete 2-year follow-up
• • 5. Females of child bearing potential not using contraception
• • 6. Pregnant females
• • 7. Nursing females