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

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ClinicalTrials.gov Identifier: NCT03348254
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Rudolf W Poolman, MD PhD, Onze Lieve Vrouwe Gasthuis

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
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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 242179 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
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 : April 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort 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




Primary Outcome Measures :
  1. Revision arthroplasty because of infection [ Time Frame: one year ]
    Revision of the hip or knee prosthesis because of infection within one year after primary surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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. 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 2015 (to allow at least one year follow-up for those operated late 2014).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348254


Locations
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Netherlands
OLVG
Amsterdam, Netherlands
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
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Principal Investigator: Rudolf W Poolman, MD PhD OLVG

Additional Information:

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Responsible Party: Rudolf W Poolman, MD PhD, MD PhD, Orthopaedic surgeon, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT03348254     History of Changes
Other Study ID Numbers: OLVG AB Profylaxe Veltman
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents