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Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Linkoeping
NCT05169229 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities. The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent. Impacted morselized bone allograft is often used

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📋 Eligibility rules (as published)
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 surgery. 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
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What it tests

  • Vancomycin + Tobramycin
  • Saline
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Where

1 site
Universitetssjukhuset Linköping
Linköping, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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