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

• Sponsor: Onze Lieve Vrouwe Gasthuis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03348254
• Collaborator: (none)
• Enrollment: 242,179
• Location: 1
• Actual Duration (Months): 35
• Patients Per Site Per Month: 6927.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Antibiotic Prophylaxis	Drug: Single shot antibiotic prophylaxis; Drug: Multiple shot antibiotic prophylaxis

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 242179 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
1 Group one will consist of patients receiving a single shot antibiotic prophylaxis preoperatively before primary arthroplasty of hip or knee	Drug: Single shot antibiotic prophylaxis; single shot preoperative antibiotic prophylaxis
2 Group two will consist of patients receiving multiple shot antibiotic prophylaxis perioperatively before and after primary arthroplasty of hip or knee	Drug: Multiple shot antibiotic prophylaxis; Multiple shot perioperative antibiotic prophylaxis

Outcome Measures

Primary Outcome Measures

1. Revision arthroplasty because of infection [one year]

   Revision of the hip or knee prosthesis because of infection within one year after primary surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OLVG	Amsterdam		Netherlands

Sponsors and Collaborators

• Onze Lieve Vrouwe Gasthuis

Investigators

• Principal Investigator: Rudolf W Poolman, MD PhD, OLVG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rudolf W Poolman, MD PhD, MD PhD, Orthopaedic surgeon, Onze Lieve Vrouwe Gasthuis
• ClinicalTrials.gov Identifier: NCT03348254
• Other Study ID Numbers: OLVG AB Profylaxe Veltman
• First Posted: Nov 20, 2017
• Last Update Posted: Mar 27, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular

Study Results

No Results Posted as of Mar 27, 2019