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

NCT03348254 | Completed DMC

• 1 other identifier: OLVG AB Profylaxe Veltman
• Study Type: observational
• Target: 242,179
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Revision arthroplasty because of infection

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

  one year

Study Arms (2)

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

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

Interventions

Single shot antibiotic prophylaxis DRUG

single shot preoperative antibiotic prophylaxis

1

Multiple shot antibiotic prophylaxis DRUG

Multiple shot perioperative antibiotic prophylaxis

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

Study Sites (1)

OLVG

Amsterdam, Netherlands

Location

Related Publications (1)

• Veltman ES, Lenguerrand E, Moojen DJF, Whitehouse MR, Nelissen RGHH, Blom AW, Poolman RW. Similar risk of complete revision for infection with single-dose versus multiple-dose antibiotic prophylaxis in primary arthroplasty of the hip and knee: results of an observational cohort study in the Dutch Arthroplasty Register in 242,179 patients. Acta Orthop. 2020 Dec;91(6):794-800. doi: 10.1080/17453674.2020.1794096. Epub 2020 Jul 23.

  PMID: 32698642 DERIVED

Study Officials

• Rudolf W Poolman, MD PhD

  OLVG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Orthopaedic surgeon

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: April 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)