Recruiting

Ancef

Sponsor:

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

Code:

NCT05604157

Conditions

Infections Joint Prosthetic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Use of Tourniquet

Study Details

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.

Conditions

Infections Joint Prosthetic

Study ID

NCT05604157

Start date

Sep 16, 2021

Status verified date

Nov, 2022

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Tourniquet

25 participants with tourniquet application

no intervention: No tourniquet

25 participants without tourniquet application

Interventions

Use of Tourniquet

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

Primary outcome measure

  • Local tissue concentrations of Cefazolin in serum, fat, synovium and bone [ Time Frame: Two years for study completion ]

Central Contacts and Locations

Locations

Dr, Adam Hart

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

More Information

Sponsor

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

Last update posted

Nov 4, 2022

Last verified

Nov, 2022

Keywords

  • Cefazolin
  • Tourniquet
  • Arthroplasty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2022-11-04.