Antibiotic Impregnated Bone Graft to reduce infection in revision hip replacement. The ABOGRAFT trial

Phase 1

• Conditions: Patients scheduled for any type of reoperation of a pre-existing hip arthroplasty requiring bone grafting; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2021-001708-14-SE
• Lead Sponsor: Region Östergötland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-12
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

* Age = 18 years
* Hip arthroplasty requiring reoperation or revision with bone graft
* Willing to provide informed consent.
* For women of childbearing potential; a negative pregnancy test prior to reoperation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960

Exclusion Criteria

* Patients with prosthetic joint infection as the reason for the reoperation
* Known allergies and contraindications for the use of vancomycin or tobramycin
* Mental inability, reluctance or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
* Expected difficulties to complete 2-year follow-up
* Women of child bearing potential not using contraception
* Pregnant women
* Nursing women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: To investigate differences between the two experimental groups in: <br>* time and cause for reoperation for any reason within 2 and 5 years <br>* time and cause for implant revision due to any reason within 2 and 5 years <br>* the type of microbe and antibiotic resistance pattern for cases complicated with post-operative infection. <br><br>Safety objective<br>To evaluate the safety of using antibiotic impregnated bone graft (AIBG) as infection prophylaxis in revision hip arthroplasty.<br>;Primary end point(s): Reoperation due to infection with bacteria that are sensitive to either vancomycin or tobramycin in the same hip joint within two years after revision hip arthroplasty. ;Timepoint(s) of evaluation of this end point: two years after revision hip arthroplasty.