Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT ID: NCT05169229

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2031-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment arm

Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.

Group Type: EXPERIMENTAL

Vancomycin + Tobramycin

Intervention Type: DRUG

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.

Placebo

Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

As a placebo added to the allograft.

Interventions

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.

Intervention Type: DRUG

Saline

As a placebo added to the allograft.

Intervention Type: DRUG

Other Intervention Names

Treatment; Control

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Östergötland

OTHER

Sponsor Role: collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Jörg Schilcher

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jörg Schilcher, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Universitetssjukhuset Linköping

Linköping, Region Östergotland, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Daphne Wezenberg, PhD

Role: CONTACT

daphne.wezenberg@liu.se

0046101030000

Facility Contacts

Jörg Schilcher, MD, PhD, Prof.

Role: primary

jorg.schilcher@liu.se

0046 101034312

daphne Wezenberg, PhD

Role: backup

daphne.wezenberg@liu.se

0046 793345789

Other Identifiers

2021-001708-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABOGRAFT-01

Identifier Type: -

Identifier Source: org_study_id