Antibiotic Impregnated Bone Graft to Reduce Infection in Revision Hip Replacement.

• Status: Not yet recruiting
• Trial end date: 2031-12-01
• Target enrollment: 0
• Participant gender: All

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 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. The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half. Unfortunately, in revision THR antibiotic impregnated bone cement in relevant quantities can seldomly be used.

The number of revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis applicable for revision THR is urgent.

Impacted morselized bone allograft is often used in revision THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in revision THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after revision hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective revision THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections 2 years postoperative.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Linkoeping
• Collaborators: Region Östergötland; The Swedish Research Council
• Treatments: Tobramycin; Vancomycin

Criteria

Inclusion Criteria:

• 1. Age ≥ 18 years 2. Hip arthroplasty requiring reoperation or revision with bone graft 3. Willing to provide informed consent. 4. For women of childbearing potential; a negative pregnancy test prior to reoperation.

Exclusion Criteria:

• 1. Patients with prosthetic joint infection as the reason for the reoperation 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. Women of child bearing potential not using contraception 6. Pregnant women 7. Nursing women