NCT05604157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

4.3 years

First QC Date

June 22, 2022

Last Update Submit

November 2, 2022

Conditions

Infections Joint Prosthetic

Keywords

CefazolinTourniquetArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Local tissue concentrations of Cefazolin in serum, fat, synovium and bone

    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

Study Arms (2)

Tourniquet

ACTIVE COMPARATOR

25 participants with tourniquet application

Other: Use of Tourniquet

No tourniquet

NO INTERVENTION

25 participants without tourniquet application

Interventions

Use of TourniquetOTHER

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

Tourniquet

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr, Adam Hart

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (14)

  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PMID: 17403800BACKGROUND

  • Bosco JA, Bookman J, Slover J, Edusei E, Levine B. Principles of Antibiotic Prophylaxis in Total Joint Arthroplasty: Current Concepts. J Am Acad Orthop Surg. 2015 Aug;23(8):e27-35. doi: 10.5435/JAAOS-D-15-00017.

    PMID: 26209148BACKGROUND

  • Fletcher N, Sofianos D, Berkes MB, Obremskey WT. Prevention of perioperative infection. J Bone Joint Surg Am. 2007 Jul;89(7):1605-18. doi: 10.2106/JBJS.F.00901. No abstract available.

    PMID: 17606802BACKGROUND

  • Bicanic G, Crnogaca K, Barbaric K, Delimar D. Cefazolin should be administered maximum 30 min before incision in total knee arthroplasty when tourniquet is used. Med Hypotheses. 2014 Jun;82(6):766-8. doi: 10.1016/j.mehy.2014.03.020. Epub 2014 Mar 25.

    PMID: 24717822BACKGROUND

  • Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8.

    PMID: 16722001BACKGROUND

  • Yamada K, Matsumoto K, Tokimura F, Okazaki H, Tanaka S. Are bone and serum cefazolin concentrations adequate for antimicrobial prophylaxis? Clin Orthop Relat Res. 2011 Dec;469(12):3486-94. doi: 10.1007/s11999-011-2111-8. Epub 2011 Oct 4.

    PMID: 21968901BACKGROUND

  • Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007/s11999-012-2469-2.

    PMID: 22773397BACKGROUND

  • Bhalodi AA, Housman ST, Shepard A, Nugent J, Nicolau DP. Tissue pharmacokinetics of cefazolin in patients with lower limb infections. Antimicrob Agents Chemother. 2013 Nov;57(11):5679-83. doi: 10.1128/AAC.01348-13. Epub 2013 Sep 16.

    PMID: 24041887BACKGROUND

  • Quintiliani R, Nightingale C. Principles of antibiotic usage. Clin Orthop Relat Res. 1984 Nov;(190):31-5.

    PMID: 6488647BACKGROUND

  • Prokuski L, Clyburn TA, Evans RP, Moucha CS. Prophylactic antibiotics in orthopaedic surgery. Instr Course Lect. 2011;60:545-55.

    PMID: 21553797BACKGROUND

  • Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis. 1998 Jan;26(1):1-10; quiz 11-2. doi: 10.1086/516284.

    PMID: 9455502BACKGROUND

  • Steinberg JP, Braun BI, Hellinger WC, Kusek L, Bozikis MR, Bush AJ, Dellinger EP, Burke JP, Simmons B, Kritchevsky SB; Trial to Reduce Antimicrobial Prophylaxis Errors (TRAPE) Study Group. Timing of antimicrobial prophylaxis and the risk of surgical site infections: results from the Trial to Reduce Antimicrobial Prophylaxis Errors. Ann Surg. 2009 Jul;250(1):10-6. doi: 10.1097/SLA.0b013e3181ad5fca.

    PMID: 19561486BACKGROUND

  • Zhang M, Moore GA, Chin PKL, Everts R, Begg EJ. Simultaneous Determination of Cefalexin, Cefazolin, Flucloxacillin, and Probenecid by Liquid Chromatography-Tandem Mass Spectrometry for Total and Unbound Concentrations in Human Plasma. Ther Drug Monit. 2018 Dec;40(6):682-692. doi: 10.1097/FTD.0000000000000555.

    PMID: 30015652BACKGROUND

  • Montreuil J, Tanzer M, Zhang YL, Rajda E, Avizonis D, Hart A. Tourniquet Use and Local Tissue Concentrations of Cefazolin During Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429702. doi: 10.1001/jamanetworkopen.2024.29702.

    PMID: 39178000DERIVED

Study Officials

  • Adam Hart, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Hart, MD

CONTACT

514-934-1934adam.hart@mgcill.ca

Karen Smith, CRA

CONTACT

514-934-1934karen.smith@muhc.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

June 22, 2022

First Posted

November 3, 2022

Study Start

September 16, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

CA(1)