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Infection Prosthesis Hip and KneePhase 3REViSIONNCT06402591

Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.

A Phase 3 study testing Cefazolin in people with Infection Prosthesis Hip and Knee and Infection, Prosthesis Related, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
Cefazolin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
751 participants
Where
1 siteNetherlands
Study dates
1 Jan 2019to 1 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older.
  • Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.

Who cannot join

  • If the index revision arthroplasty has been cancelled.
  • Revision of single mobile parts only.
  • PJI on baseline, based on 'definite infection' score according to the Philadelphia consensus definition 2018
  • PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
  • Contraindication to cefazolin:
  • Previous allergic reaction according to the criteria in Appendix A. b. Severe kidney disease defined as eGFR <10 ml/min. f. Antimicrobial treatment within 3 days prior to index revision arthroplasty. g. Subjects who are currently enrolled in investigational immunosuppressive drug trials.
  • Subjects who are unable to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland

Other trials in Netherlands

About this study

Official title: Multiple Doses Versus Single Dose of Cefazolin to Prevent Periprosthetic Joint Infection After Revision Arthroplasty: a Multicenter Open-label, Randomized Clinical Trial.

The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question[s] it aims to answer are:

  • Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee?
  • What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up?
  • What is the safety and tolerance of the antimicrobial prophylaxis regimens used?
  • What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up?
  • What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)?

[question 2] Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].

Read the detailed description

Periprosthetic joint infection (PJI) is an important complication of total joint arthroplasty of the hip and knee and occurs in 1-2% after primary arthroplasty and in 10-15% after revision arthroplasty. To prevent a PJI, peri-operative antibiotic prophylaxis is given. There's inadequate evidence for a recommendation about the optimal duration of prophylaxis, especially in revision arthroplasty. The aim of this multicenter open-label, randomized controlled trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. Patients will be recruited at the orthopedic departments of two Dutch hospitals, University Medical Center Radboudumc Nijmegen (Radboudumc) and Sint Maartenskliniek in Nijmegen (SMK). Patients will be included if they will undergo revision arthroplasty of the hip or knee, with exclusion of patients with a proven PJI at baseline. A total of 780 subjects will be randomized between 2 prophylactic strategies: A) Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before incision; B) Cefazolin at a dose of 2 grams intravenously 15-60 minutes before incision, followed by cefazolin 1 gram intravenously t.i.d. until five days post-surgery. The primary endpoint is the difference in proportion of infectious-free implant survival between both groups within 1 year of follow-up.

Being tested
Cefazolin
Medical subject headings
Prosthesis-Related Infections, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefazolinDrug

    cefazolin extended prophylaxis 5 days (15 doses)

Study groups in NCT06402591
Study groupRoleWhat they receive
single dose cefazolin prophylaxisNo interventionprophylaxis according current guidelines single dose 2000mg cefazolin 15-30 minutes before incision
extended cefazolin prophylaxisExperimental5 days of cefazolin prophylaxis start dose 2000mg followed by 14 doses of 1000mg
Receives: Drug: Cefazolin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of revision arthroplasty

    1. Implant retention during follow-up,
    2. No 'definite infection' score for PJI according to the Philadelphia consensus definition 2018 during follow-up
    3. No PJI based on positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacteriaceae, Pseudomonas spp, Acinetobacter spp, Candida spp) during follow-up.
    4. No more than 4 consecutive weeks of systemic antimicrobial therapy for any reason during follow-up.

    Measured: 1 year after revision arthroplasty

Secondary outcomes (9)

  1. incidence surgical site infections

    1. The proportion of SSI according to PREZIES (PREventie van ZIEkenhuisinfecties door Surveillance) criteria in both study groups during follow-up.

    Measured: 1 year after revision arthroplasty

  2. incidence periprosthetic joint infection

    The proportion of PJI according to Philadelphia consensus definition 2018 in both study groups during follow-up.

    Measured: 1 year after revision arthroplasty

  3. resistance rate of causative of SSI/PJI to cefazolin

    The cefazolin susceptibility of the micro-organisms causing SSI and PJI in the study groups.

    Measured: 1 year after revision arthroplasty

  4. The number of repeated surgeries.

    The number of repeated surgeries.

    Measured: 1 year after revision arthroplasty

  5. Reason repeated surgery

    The reason for repeated surgery on the affected prosthetic joint during follow-up.

    Measured: 1 year after revision arthroplasty

  6. adverse drug events

    Adverse drug events and serious adverse events.

    Measured: 1 year after revision arthroplasty

  7. Risk factors associated with SSI and PJI: BMI, age, age of implant before revision,

    Risk factors associated with SSI and PJI: BMI, age, age of implant before revision, number of previous revisions before index

    Measured: 1 year after revision arthroplasty

  8. Implant survival at the end of the study.

    Implant survival at the end of the study.

    Measured: during inclusion of the study

  9. Patient related outcome measurements

    PROMs at weeks 12 and 52

    Measured: 1 year after revision arthroplasty

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start1 Jan 2019
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
randomized controled trial
Masking
None (open label)
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402591
Sponsor's protocol ID
NL70114.091.19
Acronym
REViSION
Status last verified
May 2024
First submitted
7 Apr 2023
Last updated
7 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cefazolin in people with Infection Prosthesis Hip and Knee and Infection, Prosthesis Related, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of revision arthroplasty (time frame: 1 year after revision arthroplasty). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06402591.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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