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Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT05169229 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2025-07-22

No results posted yet for this study

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.

Conditions

  • Arthroplasty, Replacement, Hip
  • Osteoarthritis, Hip
  • Antibiotic Resistant Infection
  • Prosthetic Joint Infection

Interventions

DRUG

Vancomycin + Tobramycin

1 g vancomycin (powder) diluted in 8 ml tobramycin (40 -80mg/ml). Added to the prepared allograft before the allograft is used during the revision surgery.

DRUG

Saline

As a placebo added to the allograft.

Sponsors & Collaborators

  • Region Östergötland

    collaborator OTHER

  • The Swedish Research Council

    collaborator OTHER_GOV

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Jörg Schilcher, PhD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2028-12-31
Completion
2031-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05169229 on ClinicalTrials.gov