Antibiotic Prophylaxis in Primary Joint Arthroplasty of the Hip and Knee.

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Single Shot Versus Multiple Shot Antibiotic Prophylaxis in Primary Joint Arthroplasty of the Hip and Knee, Comparison of Different Prophylaxis Regimes on the Risk of Revision for Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348254
• Other study ID #: OLVG AB Profylaxe Veltman
• Status: Completed
• Start date: April 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A retrospective study will be performed to compare the incidence of revision procedures performed for the treatment of postoperative periprosthetic joint infection (PJI) between patients treated with a single preoperative antibiotic prophylaxis and patients treated with multiple shot antibiotic prophylaxis following primary arthroplasty of hip or knee.

This study will be conducted in two phases. In phase 1 the investigators will evaluate which antibiotic prophylaxes (type of antibiotic and duration of prophylaxis) are regularly used in the Netherlands, by contacting all orthopaedic centres implanting total hip and total knee prostheses. In phase 2 the investigators will compare infection rate (defined as revision for infection as registered in the LROI database) between a single-shot and multiple shot antibiotic prophylaxis.

Knee and hip primary arthroplasties will be considered separately.

Description:

In phase 1 of this study all Dutch hospitals and clinics performing hip and/or knee arthroplasty will be contacted to supply data concerning type and duration of antibiotic prophylaxis. The investigators will also ask whether debridement with implant retention for early infection is registered in the LROI. The investigators will ask permission to have access to unblended data on institutional level to be able to connect the type of antibiotic prophylaxis to outcome.

In phase 2 the investigators will include all adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (LROI) between 2011 and 2016.Those patients will be followed until they are revised (irrespectively of the indication), they died or the end-point of the study, i.e. end of 2016 (to allow at least one year follow-up for those operated late 2015).

Exclusion criteria are patients aged under 18. Patients with no primary procedure recorded in the LROI for the period of interest but records of revision surgeries will be excluded.

The investigators will compare the results found in the LROI database in two groups for both hip and knee arthroplasties. Group one will consist of patients receiving a single shot antibiotic prophylaxis, while group two will consist of patients receiving multiple shot antibiotic prophylaxis.

Analyses will be adjusted for known and available confounders such as age, gender, BMI, and ASA score.

In the LROI debridement without exchange of mobile parts for early infection, is only scarcely reported. The authors realise not all early infection treatments, such as debridement with or without exchange of mobile parts, are registered in the LROI database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242179
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (LROI) between 2011 and 2014

Exclusion Criteria:

• Patients aged under 18.

• Patients with no primary procedure recorded in the LROI for the period of interest but records of revision surgeries will be excluded.

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

Drug:
• Single shot antibiotic prophylaxis
single shot preoperative antibiotic prophylaxis
• Multiple shot antibiotic prophylaxis
Multiple shot perioperative antibiotic prophylaxis

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision arthroplasty because of infection	Revision of the hip or knee prosthesis because of infection within one year after primary surgery	one year