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NCT05169229 | RECRUITING | Arthroplasty, Replacement, Hip

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.
Sponsor:

University Hospital, Linkoeping

Information provided by (Responsible Party):

Jörg Schilcher

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 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 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 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 hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective 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 and PJI diagnoses 2 years postoperative.

Condition or disease

Arthroplasty, Replacement, Hip

Osteoarthritis, Hip

Antibiotic Resistant Infection

Prosthetic Joint Infection

Intervention/treatment

Vancomycin + Tobramycin

Saline

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1100 participants
Masking : QUADRUPLE
Masking Description : Double-blinded
Primary Purpose : TREATMENT
Official Title : Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
Actual Study Start Date : 2022-04-01
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2031-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Location Details

NCT05169229

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How to Participate

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Locations

RECRUITING

Sweden, Region Östergotland

Linköping University Hospital

Linköping, Region Östergotland, Sweden, 58185