Infection of Total Knee Joint ProsthesisNCT03192124
Evaluating Bactisure Wound Lavage in Orthopedic Wounds
An observational study of Infection of Total Knee Joint Prosthesis, run by Zimmer Biomet at 5 sites in United States.
Trial summary
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Total Knee Joint Prosthesis
- What is being tested?
- Bactisure
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jul 2017to 22 Mar 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential Subjects (M and F, age 18 years or older) diagnosed with Prosthetic Joint Infection (PJI) following primary total knee (TKA) implantation, who are undergoing I \& D or reoperation (revision) surgery
Who may be able to join
- Patient is undergoing I \& D or reoperation (revision) surgery for an infected primary TKA.
- Patient is 18 years of age or greater.
- Patient is skeletally mature.
- Occurs within 30 days of the operation or within 1 year or more if an implant is present
- Involves deep soft tissues (e.g., fascia and/or muscle) of the incision
- Patient is willing and able to provide written informed consent.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol
Who cannot join
- Patients will be excluded from this study if:
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution
- Multiple (>1) infected implants
- Medically unfit for irrigation \& debridement procedure
- Pregnancy
Show all 10Show fewer
- The patient is:
- prisoner
- mentally incompetent or unable to understand what participation in the study entails
- anticipated to be non-compliant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Cleveland Clinic
Cleveland, Ohio, 22644
University of Kentucky Orthopedic Spine & Total Joint Service
Lexington, Kentucky, 40508
LA Orthopedic Institute
Los Angeles, California, 90057
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, 40241
The Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
Read the detailed description
This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage.
This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I \& D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.
- Conditions
- Infection of Total Knee Joint Prosthesis
- Being tested
- Bactisure
- Keywords
- primary total knee, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BactisureDevice
Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin.
Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction WBC
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage
Measured: Intraoperative
Secondary outcomes (1)
Bacteria Identification
To quantitatively and qualitatively assess the synovial fluid for the presence of bacteria prior to and after lavage. This testing will compare the microbial population (species) of the surgical wounds by serial culture dilution, and bacterial identification by PCR before and after irrigation.
Measured: One Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jul 2017
- Primary completion22 Dec 2018
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Total Knee Joint ProsthesisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kacy Arnold, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192124
- Sponsor's protocol ID
- H.CR.I.AM.16.10
- Status last verified
- Jan 2020
- First submitted
- 15 Jun 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds
- ClinicalTrials.gov ID
- NCT03192124
- Acronym / sponsor ID
- H.CR.I.AM.16.10
- Conditions
- Infection of Total Knee Joint Prosthesis
- Keywords
- primary total knee, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
Detailed description
This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage.
This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I \& D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential Subjects (M and F, age 18 years or older) diagnosed with Prosthetic Joint Infection (PJI) following primary total knee (TKA) implantation, who are undergoing I \& D or reoperation (revision) surgery
Key inclusion criteria (7 listed)
- Patient is undergoing I \& D or reoperation (revision) surgery for an infected primary TKA.
- Patient is 18 years of age or greater.
- Patient is skeletally mature.
- Occurs within 30 days of the operation or within 1 year or more if an implant is present
- Involves deep soft tissues (e.g., fascia and/or muscle) of the incision
Key exclusion criteria (10 listed)
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Known sensitivity or allergic reaction to benzalkonium chloride one or more of the solvent, chelating agent, or buffer in the solution
- Multiple (>1) infected implants
- Medically unfit for irrigation \& debridement procedure
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BactisureLevel 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin. Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present. | Device | – |
Primary outcome
Reduction WBC
Time frame: Intraoperative
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage
1 secondary outcome
Bacteria Identification
Time frame: One Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kacy Arnold, MBA study director
Zimmer Biomet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection of Total Knee Joint Prosthesis, run by Zimmer Biomet at 5 sites in United States.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction WBC (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.