Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Osteoarthritis, Hip Clinical Trial

— ABOGRAFT  

Official title:

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169229
• Other study ID #: ABOGRAFT-01
• Secondary ID: 2021-001708-14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2022
• Est. completion date: December 2031

Study information

• Verified date: November 2023
• Source: University Hospital, Linkoeping
• Contact: Daphne Wezenberg, PhD
• Phone: 0046101030000
• Email: daphne.wezenberg[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: December 2031
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Women of child bearing potential not using contraception

6. Pregnant women

7. Nursing women

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Arthroplasty, Replacement, Hip
• Communicable Diseases
• Infections
• Osteoarthritis, Hip
• Prosthetic Joint Infection

Intervention

Drug:
• Vancomycin + Tobramycin
1 g vancomycin (powder) diluted in 8 ml tobramycin (80mg/ml). Added to the prepared allograft before the allograft is used during the revision surgery.
• Saline
As a placebo added to the allograft.

Locations

Country	Name	City	State
Sweden	Universitetssjukhuset Linköping	Linköping	Region Östergotland

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Region Östergötland, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences between the two experimental groups regarding the frequencies of adverse events	Differences between the two experimental groups regarding the frequencies of adverse events	2 and 5 years after finalizing data collection.
Other	Differences between the two experimental groups regarding the rates of revision due to aseptic loosening	Differences between the two experimental groups regarding the rates of revision due to aseptic loosening	2 and 5 years after finalizing data collection.
Primary	Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty.	Reoperation due to infection or diagnosed PJI 2 years of revision surgery.	2 years after finalizing data collection.
Secondary	Time and cause for reoperation for any reason within 2 and 5 years	Time and cause for reoperation for any reason within 2 and 5 years	2 and 5 years after finalizing data collection.
Secondary	Time and cause for implant revision due to any reason within 2 and 5 years	Time and cause for implant revision due to any reason within 2 and 5 years	2 and 5 years after finalizing data collection.
Secondary	Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection	Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection	2 and 5 years after finalizing data collection.