Ancef Dosage in Knee Arthroplasty : Tourniquet Clinical Trial

NCT ID: NCT05604157

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2025-12-31

Brief Summary

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.

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.

Conditions

Infections Joint Prosthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tourniquet

25 participants with tourniquet application

Group Type: ACTIVE_COMPARATOR

Use of Tourniquet

Intervention Type: OTHER

Application of tourniquet or not in adults undergoing a primary total knee replacement.

No tourniquet

25 participants without tourniquet application

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Use of Tourniquet

Application of tourniquet or not in adults undergoing a primary total knee replacement.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Adam Hart

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Hart, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Dr, Adam Hart

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Adam Hart, MD

Role: CONTACT

adam.hart@mgcill.ca

514-934-1934 ext. 43040

Karen Smith, CRA

Role: CONTACT

karen.smith@muhc.mcgill.ca

514-934-1934 ext. 43040

Facility Contacts

Adam Hart, MD

Role: primary

adam.hart@mcgill.ca

514-934-1934 ext. 43040

Karen Smith

Role: backup

karen.smith@muhc.mcgill.ca

514-934-1934 ext. 43040

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Other Identifiers

2021-6782

Identifier Type: -

Identifier Source: org_study_id