Ancef Dosage in Knee Arthroplasty : Tourniquet Clinical Trial

November 2, 2022 updated by: Adam Hart, McGill University Health Centre/Research Institute of the McGill University Health Centre

Effect of Tourniquet on Local Tissue Concentrations of Cefazolin During Total Knee Arthroplasty: A Randomized Controlled Trial

Tourniquet inflation during total knee arthroplasty (TKA) is commonly used to reduce bleeding in the surgical field; thereby facilitating exposure and cementation. However, reducing circulation to the leg may also reduce antibiotic distribution to the peri-incisional tissues. Once inflated, further parenteral addition of antibiotics is not likely to achieve peak concentration. Some studies propose techniques of regional prophylaxis with a tourniquet to achieve higher cefazolin tissue concentrations. To our knowledge, the effect of tourniquet application on antibiotic tissue concentrations during total knee arthroplasty has not been explored. Furthermore, the effect of time from dose to incision, participants weight, and length of surgery on local tissue concentrations of Ancef are poorly understood. Considering that infections remain the leading source of early reoperation and revision surgery, insight and optimization of local tissue antibiotics is of paramount interest.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In Canada, over 130 000 cases of primary joint arthroplasty are performed annually, and this number is increasing steadily with the aging population. Projections from the United States estimate that, by 2030, more than 3.5 million primary joint arthroplasties will be performed annually. Although rare, with reported rates of 0.5-2% within 2 years, periprosthetic joint infection (PJI) is a devastating complication with serious morbidity. Effective use of antibiotic prophylaxis remains an important measure to prevent progression of an intraoperative contamination of the surgical site to an overt clinical infection. It creates a hostile environment in blood and tissue inhibiting pathogens that could contaminate the wound throughout the procedure. In order to be effective, the concentration of antibiotic must exceed the minimum inhibitory concentration (MIC) of the organism between skin incision and wound closure. S. aureus and Coagulase-negative staphylocci (CoNS), including S.epidermidis, cause close to half of deep infections and reported MIC ranges from 0.5 to 8 ug/ml in bone. Achieving fourfold MIC in tissue is recommended for halting the pathogen Cefazolin, efficient against most common pathogens in orthopaedics, has a good tissue penetration, minimal toxicity, low cost, and therefore is the antibiotic of choice in arthroplasty procedures. Pharmacokinetics studies have showed that Cefazolin achieves peak bone concentrations 40 minutes after parenteral application and based on systemic dosage methods, guidelines recommend that the antibiotic should be infused within 60 minutes before surgical incision. Compared to conventional systemic dosing, modern techniques using liquid chromatography and mass spectrometry can adequately measure antibiotic concentration in tissue like fat and bone.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ages 18-85 who require a primary total knee replacement
  • Any gender
  • Osteoarthritis, rheumatoid arthritis, avascular necrosis

Exclusion Criteria:

  • Severe allergy to antibiotic used in the study
  • Severe renal dysfunction (eGFR < 30 ml/min)
  • Methicillin-resistant Staphylococcus aureus (MRSA) colonization
  • participants who require revision surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tourniquet
25 participants with tourniquet application
Other: Use of Tourniquet
Application of tourniquet or not in adults undergoing a primary total knee replacement.
No Intervention: No tourniquet
25 participants without tourniquet application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tissue concentrations of Cefazolin in serum, fat, synovium and bone
Time Frame: Two years for study completion
The principle intervention in this study will be the application of a tourniquet or no tourniquet during the procedure and its effect on local tissue concentrations of Cefazolin
Two years for study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Adam Hart, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-6782

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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