Tourniquet Use for Prosthetic Joint Infections

Recruiting at 1 trial location

Overseen By Karen Smith, CRA

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Severe allergy, Renal dysfunction, MRSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how using a tourniquet (a tight band) during knee replacement surgery affects antibiotic levels in tissues. The researchers aim to determine whether a tourniquet helps or hinders the spread of Ancef, an antibiotic used to prevent infections. Participants are divided into two groups: one with a tourniquet and one without. The trial seeks adults needing their first total knee replacement due to conditions like osteoarthritis or rheumatoid arthritis. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that tourniquet use during total knee arthroplasty is safe?

Research shows that using a tourniquet during total knee replacement surgery can reduce bleeding, allowing surgeons to see better and work more quickly. However, some studies suggest that a tourniquet might increase infection risk. One analysis found a higher infection risk in surgeries with a tourniquet. Another study noted that longer surgeries, which can occur with tourniquet use, also had a higher infection risk.

The main treatment in this study is Ancef, an FDA-approved antibiotic for preventing infections during surgeries. Ancef is generally considered safe for people. However, the effect of a tourniquet on Ancef's distribution in the body is not fully understood, and this study aims to explore that. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of using a tourniquet during surgery for prosthetic joint infections. Currently, standard treatments focus on antibiotics like Ancef and surgical interventions without specific protocols for tourniquet use. This study could reveal whether applying a tourniquet can enhance the delivery of antibiotics to the infected area or improve surgical outcomes. By comparing outcomes with and without tourniquet application, the trial aims to determine if this method could be a game-changer in managing prosthetic joint infections more effectively.

What evidence suggests that tourniquet use is effective for prosthetic joint infections?

This trial will compare knee replacement surgeries with and without a tourniquet. Research has shown that using a tourniquet can reduce the amount of antibiotics, like Ancef, that reach the tissues around the knee. Studies have found that tourniquets lower antibiotic levels in fat, the joint lining, and bone within 60 minutes after administration. This reduction might occur because the tourniquet decreases blood flow, limiting antibiotic delivery to the area. Conversely, tourniquets can help reduce bleeding during surgery, which is crucial for maintaining a clear surgical area. However, some research suggests that using a tourniquet might increase the risk of infection. While tourniquets offer surgical benefits, their impact on antibiotic effectiveness remains under investigation. ^{1 4 6 7 8}

Who Is on the Research Team?

Adam Hart, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

Adults aged 18-85 needing a primary total knee replacement due to conditions like osteoarthritis, rheumatoid arthritis, or avascular necrosis can join. Those with MRSA colonization, severe allergies to the study antibiotic, or severe kidney issues (eGFR < 30 ml/min) cannot participate.

Inclusion Criteria

My gender does not limit my participation.

I have been diagnosed with osteoarthritis, rheumatoid arthritis, or avascular necrosis.

I am between 18 and 85 years old and need a knee replacement.

Exclusion Criteria

Severe allergy to antibiotic used in the study

Methicillin-resistant Staphylococcus aureus (MRSA) colonization

My kidney function is severely reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty with or without tourniquet application to study the effect on local tissue concentrations of Cefazolin

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Ancef

Trial Overview The trial is testing how using a tourniquet during knee surgery affects the concentration of Ancef (an antibiotic) in tissue around the incision. It's looking at whether less blood flow from the tourniquet means less antibiotic gets to where it's needed.

How Is the Trial Designed?

Group I: Tourniquet Active Control 1 Intervention

25 participants with tourniquet application

Group II: No tourniquet Active Control 1 Intervention

25 participants without tourniquet application

Ancef is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ancef for:

• Surgical prophylaxis
• Respiratory tract infections
• Skin and skin structure infections
• Bone and joint infections
• Genitourinary tract infections
• Septicemia

Approved in European Union as Cefazolin for:

• Surgical prophylaxis
• Respiratory tract infections
• Skin and skin structure infections
• Bone and joint infections
• Genitourinary tract infections
• Septicemia

Approved in Canada as Kefzol for:

• Surgical prophylaxis
• Respiratory tract infections
• Skin and skin structure infections
• Bone and joint infections
• Genitourinary tract infections
• Septicemia

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Published Research Related to This Trial

In a study of 24 patients undergoing total knee arthroplasty, a five-minute interval between cefazolin administration and tourniquet inflation resulted in significantly better penetration of the antibiotic into soft tissue compared to one-minute intervals, achieving a median penetration of 14.5%.

The five-minute group also had a higher percentage of patients reaching the desired cefazolin concentration for effective infection prophylaxis, indicating that this timing may optimize antibiotic efficacy during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis and tourniquet inflation in total knee arthroplasty. Friedman, RJ., Friedrich, LV., White, RL., et al.[2013]

Cefazolin (Ancef) is a first-generation cephalosporin antibiotic commonly used in surgeries to prevent bacterial infections, and it is generally considered safe for most patients.

Despite concerns about cross-reactivity with penicillin allergies, the article aims to investigate the safety of cefazolin for patients with such allergies, suggesting that it may be a viable option rather than using less effective alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Cephalosporins Safe for Surgical Prophylaxis in Patients with Penicillin Allergy? Abraham-Aggarwal, K., Kacker, A.[2023]

A study involving 27,467 surgeries showed that using cefazolin as surgical prophylaxis in patients with penicillin allergies, including those with anaphylaxis histories, did not result in increased allergic reactions or adverse events compared to other antibiotics.

After implementing a policy change to routinely use cefazolin, there were no documented cases of anaphylaxis in penicillin-allergic patients, indicating that cefazolin is a safe option for surgical prophylaxis in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of administering cefazolin versus other antibiotics in penicillin-allergic patients for surgical prophylaxis at a major Canadian teaching hospital. Grant, JM., Song, WHC., Shajari, S., et al.[2021]

Staphylococcus epidermidis is a major cause of postoperative infections in orthopedic surgeries, leading to the use of antibiotics like cefazolin and cefuroxime for prevention, but increasing methicillin-resistant strains have necessitated the use of glycopeptide antibiotics like vancomycin and teicoplanin.

Regional prophylaxis with teicoplanin during total knee replacement surgery has been shown to be safe and effective, providing higher antibiotic concentrations at the surgical site and achieving similar infection rates compared to traditional systemic prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in orthopedic prosthetic surgery. de Lalla, F.[2022]

In a study of 228 surgical patients, cefazolin was found to significantly reduce the rate of major postoperative wound infections (2.56% vs. 4.50%) compared to amoxicillin + gentamycin.

Cefazolin also led to fewer minor postoperative wound infections (6.83% vs. 13.51%) and could potentially save 68.75% of the costs associated with antibiotic prophylaxis by limiting the duration of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single preoperative dose of cefazolin versus postoperative amoxicillin and gentamycin combination in prophylaxis of orthopaedic and traumatologic surgery. Perçin, S., Akbaş, L., Akbaş, A.[2017]

A study involving 2289 surgeries across three trauma centers found that administering cephalosporins to pediatric patients with a reported penicillin allergy did not lead to a higher rate of allergic reactions compared to those without such allergies.

Only one patient experienced an anaphylactic reaction to cefazolin, indicating that cephalosporins can be safely used in pediatric orthopedic patients labeled as penicillin-allergic, thus supporting their use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical prophylaxis in pediatric orthopedic patients with penicillin allergy: a multicentered retrospective prognostic study. Khokhar, AS., Batko, BD., Hanna, G., et al.[2023]

In a study involving 18 patients undergoing total knee arthroplasty, a 2 g dose of intravenous cefazolin resulted in significantly higher intraosseous concentrations compared to a 1 g dose, indicating a potential for improved drug delivery to the surgical site.

Despite the increased concentrations of cefazolin with the 2 g dose, there was no corresponding increase in its effectiveness against Staphylococcus aureus growth, suggesting that higher doses may not necessarily enhance antibacterial efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraosseous concentration and inhibitory effect of different intravenous cefazolin doses used in preoperative prophylaxis of total knee arthroplasty. Angthong, C., Krajubngern, P., Tiyapongpattana, W., et al.[2018]

Parenteral prophylactic antibiotics, particularly first-generation cephalosporins like Cefazolin, are effective in reducing infection rates in clean orthopedic procedures, supported by numerous animal and clinical studies.

Administering the antibiotic at the start of anesthesia or at least 10 minutes before tourniquet inflation is crucial, and 24 hours of postoperative coverage is generally sufficient for effective infection prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of parenteral prophylactic antibiotics in clean orthopaedic surgery. A review of the literature. Oishi, CS., Carrion, WV., Hoaglund, FT.[2022]

Periprosthetic infections, particularly from Staphylococcus aureus and Staphylococcus epidermidis, occur in 0.4-2% of total knee arthroplasty patients, making effective antibiotic prophylaxis crucial.

The study suggests that administering cefazolin 10 to 30 minutes before tourniquet inflation could optimize its peak concentrations in both blood and bone, enhancing its effectiveness in preventing infections during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefazolin should be administered maximum 30 min before incision in total knee arthroplasty when tourniquet is used. Bicanic, G., Crnogaca, K., Barbaric, K., et al.[2014]

In a study of 76 patients undergoing total hip or knee replacement, cefonicid showed no toxicity and was compared to cefazolin, with both drugs demonstrating safety in the short follow-up period of four months to one year.

No significant difference in efficacy was found between cefonicid and cefazolin in preventing infections, indicating that larger studies with longer follow-up are needed to assess the potential benefits of cefonicid over the established drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind study comparing cefonicid with cefazolin as prophylaxis in patients undergoing total hip or knee replacement. DeBenedictis, KJ., Rowan, NM., Boyer, BL.[2019]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822773

Tourniquet Use and Local Tissue Concentrations of ... In this randomized clinical trial of 59 adults, the use of a tourniquet resulted in significantly lower concentrations in fat, synovium, and bone by 60 minutes ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39178000/

Tourniquet Use and Local Tissue Concentrations of ... The use of a tourniquet resulted in significantly lower mean LTCs by 60 minutes after cefazolin infusion (10.8 μg/g [95% CI, 9.1-12.4 μg/g] vs ...

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06257-2

Periprosthetic joint infection after arthroplasty: advances and ... The use of an intraoperative tourniquet is effective in reducing intraoperative bleeding, providing a clear surgical field and shortening ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05604157?term=GRAMAXIN&rank=4

Ancef Dosage in Knee Arthroplasty : Tourniquet Clinical Trial Although rare, with reported rates of 0.5-2% within 2 years, periprosthetic joint infection (PJI) is a devastating complication with serious morbidity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9249956/

Tourniquet use in total knee arthroplasty and the risk of ... This meta-analysis of RCTs suggested that tourniquet use in TKA was associated with an increased overall risk of infection, intraoperative blood ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514936/

Patient-related risk factors of prosthetic joint infections ... General anesthesia was used in almost 21% of the patients and was significantly associated with a higher risk of infection (p = 0.049). An ...

7. mdpi.com mdpi.com/2077-0383/13/11/3046

Greater Risk of Periprosthetic Joint Infection Associated ... A higher risk of PJI was noted in surgeries lasting over 90 or 120 min compared to those of shorter duration (90 min, pooled OR = 1.50, p < 0.01; 120 min, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195670125000234

Trends in surgical site infection and periprosthetic joint ... Association of tourniquet use on short-term implant survival after primary total knee arthroplasty: a study of 24,249 knees from the Norwegian Arthroplasty ...