Prosthetic Joint InfectionNCT03717090
Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption
An observational study of Prosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Joint Infection
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2016to 31 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 cc. The sample was partitioned between two set of aerobic and anaerobic BCBs (at least 2.5cc for each bottle), wound culture tube (2cc), synovial fluid analysis (2cc). In instances where there is insufficient fluid to send all 3 modalities (less than 14 mL), patients will be excluded from the current investigation. Samples will be delivered to the clinical microbiology laboratory within a 2-hour period.
Who may be able to join
None listed.
Who cannot join
- Patients not meeting MSIS criteria
- Patients undergoing aseptic revision
- Insufficient synovial fluid amount for analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption Ionization Time-of-flight Mass Spectrometry
This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room.
The purpose of this study will be to evaluate that 1) the concordance of organism identification by the direct identification of MALTI-TOF MS versus routine identification of MALTI-TOF MS and conventional cultures and 2) the timing of preliminary strain identification by the direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures in patients with periprosthetic joint infection.
Read the detailed description
Material and Methods
- Patients who have a high probability of infection based on the Musculoskeletal Infection Society (MSIS) criteria and are scheduled for debridement only or debridement with implant removal, will be invited to enroll the study after signed informed consent. The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 ccs. The sample will be divided between MALDI-TOF mass spectrometry in standard blood culture bottles (10 ccs), wound culture tube (2 ccs), and synovial fluid analysis (2 ccs). The samples will be delivered to microbiology laboratory within a 2-hour period.
- Bacterial culture and conventional identification Bacterial identification will be performed by the conventional method using the Vitek 2 system. For the conventional culture, 1 µL of well-mixed synovial joint fluid will be inoculated and spread onto blood agar plates and MacConkey agar plates using a sterile plastic disposable loop. Plates will be incubated in an aerobic atmosphere at 37℃ for 18-24 hr. When bacterial growth is observed, the colonies on blood agar will be counted, and colonies from both types of plates will be identified by using the Vitek 2 system.
- MALDI-TOF MS identification The suspension obtained following the above sample preparation will be centrifuged at 13,000g for 2 minutes, and the supernatant will be discarded. The pellet will be centrifuged at 13,000g for another 2 minutes prior to the removal of the residual ethanol. Fifty microliters of formic acid (70% v/v) and 50 mL of 100% acetonitrile will be added to the pellet, and mixed thoroughly after each reagent is added. The suspension will be centrifuged again at 13,000g for another 2 minutes, and 1 mL of the supernatant will be spotted onto the steel target plate. Analysis will be performed following air-drying of 1 mL a-cyano-4-hydroxycinnamic acid matrix solution placed onto the dried sample spot in duplicate. Mass spectra profiles will be acquired using a microflex LT MALDI-TOF mass spectrometer (Bruker Daltonics, Bremen, Germany) following the manufacturer's settings. Spectra will be recorded in the linear positive mode at a laser frequency of 60 Hz within a mass range from 2000 Da to 20,000 Da. All bacteria identifications will be performed by MALDI-TOF Biotyper RTC and the Bruker MALDI Biotyper 3.1 software and library (4613 isolates; Bruker Daltonics). Criteria used for microorganism analysis and identification will be as recommended by the manufacturer.
- Statistical analysis Time to identification will be determined as the time from colony formation to the time at which the final result is reported to a physician. Statistical analysis will be performed to compare the three methods using Chi-square tests. The level of statistical significance will be set at p < 0.05.
- Conditions
- Prosthetic Joint Infection
- Being tested
- No intervention
- Keywords
- mass spectrometry, diagnosis, prosthetic joint infection, matrix-assisted laser desorption ionization
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Sample collection study Sample collection and collection of laboratory values
| Study group | Role | What they receive |
|---|---|---|
| Patients with PJI | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification rate of microorganisms
The organism identification from direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures
Measured: Immediate post-operative period (usually within 5-7 days following surgery)
Secondary outcomes (1)
The timing of organism identification
The timing of preliminary strain identification of direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures
Measured: Immediate post-operative period (usually within 5-7 days following surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Dec 2016
- Primary completion30 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Chih Kuo, Chang Gung Memorial Hospital
- Investigators
- Feng-Chih Kuo, MD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717090
- Sponsor's protocol ID
- CMRPG8F1402
- Status last verified
- Aug 2019
- First submitted
- 22 Oct 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peersman G, Laskin R, Davis J, Peterson M. Infection in total knee replacement: a retrospective review of 6489 total knee replacements. Clin Orthop Relat Res. 2001 Nov;(392):15-23.
PubMed 11716377Fink B, Makowiak C, Fuerst M, Berger I, Schafer P, Frommelt L. The value of synovial biopsy, joint aspiration and C-reactive protein in the diagnosis of late peri-prosthetic infection of total knee replacements. J Bone Joint Surg Br. 2008 Jul;90(7):874-8. doi: 10.1302/0301-620X.90B7.20417.
PubMed 18591595Geller JA, MacCallum KP, Murtaugh TS, Patrick DA Jr, Liabaud B, Jonna VK. Prospective Comparison of Blood Culture Bottles and Conventional Swabs for Microbial Identification of Suspected Periprosthetic Joint Infection. J Arthroplasty. 2016 Aug;31(8):1779-83. doi: 10.1016/j.arth.2016.02.014. Epub 2016 Feb 24.
PubMed 27020677Peel TN, Dylla BL, Hughes JG, Lynch DT, Greenwood-Quaintance KE, Cheng AC, Mandrekar JN, Patel R. Improved Diagnosis of Prosthetic Joint Infection by Culturing Periprosthetic Tissue Specimens in Blood Culture Bottles. mBio. 2016 Jan 5;7(1):e01776-15. doi: 10.1128/mBio.01776-15.
PubMed 26733067Croxatto A, Prod'hom G, Greub G. Applications of MALDI-TOF mass spectrometry in clinical diagnostic microbiology. FEMS Microbiol Rev. 2012 Mar;36(2):380-407. doi: 10.1111/j.1574-6976.2011.00298.x. Epub 2011 Aug 22.
PubMed 22092265Haiko J, Savolainen LE, Hilla R, Patari-Sampo A. Identification of urinary tract pathogens after 3-hours urine culture by MALDI-TOF mass spectrometry. J Microbiol Methods. 2016 Oct;129:81-84. doi: 10.1016/j.mimet.2016.08.006. Epub 2016 Aug 5.
PubMed 27503535
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption Ionization Time-of-flight Mass Spectrometry
- ClinicalTrials.gov ID
- NCT03717090
- Acronym / sponsor ID
- CMRPG8F1402
- Conditions
- Prosthetic Joint Infection
- Keywords
- mass spectrometry, diagnosis, prosthetic joint infection, matrix-assisted laser desorption ionization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 24 Oct 2018 (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.
This is a prospective cohort study. All patients presenting for periprosthetic joint infection and requiring debridement only or resection arthroplasty will be eligible. The synovial joint fluid will be sampled before the arthrotomy at the operation room.
The purpose of this study will be to evaluate that 1) the concordance of organism identification by the direct identification of MALTI-TOF MS versus routine identification of MALTI-TOF MS and conventional cultures and 2) the timing of preliminary strain identification by the direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures in patients with periprosthetic joint infection.
Detailed description
Material and Methods
- Patients who have a high probability of infection based on the Musculoskeletal Infection Society (MSIS) criteria and are scheduled for debridement only or debridement with implant removal, will be invited to enroll the study after signed informed consent. The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 ccs. The sample will be divided between MALDI-TOF mass spectrometry in standard blood culture bottles (10 ccs), wound culture tube (2 ccs), and synovial fluid analysis (2 ccs). The samples will be delivered to microbiology laboratory within a 2-hour period.
- Bacterial culture and conventional identification Bacterial identification will be performed by the conventional method using the Vitek 2 system. For the conventional culture, 1 µL of well-mixed synovial joint fluid will be inoculated and spread onto blood agar plates and MacConkey agar plates using a sterile plastic disposable loop. Plates will be incubated in an aerobic atmosphere at 37℃ for 18-24 hr. When bacterial growth is observed, the colonies on blood agar will be counted, and colonies from both types of plates will be identified by using the Vitek 2 system.
- MALDI-TOF MS identification The suspension obtained following the above sample preparation will be centrifuged at 13,000g for 2 minutes, and the supernatant will be discarded. The pellet will be centrifuged at 13,000g for another 2 minutes prior to the removal of the residual ethanol. Fifty microliters of formic acid (70% v/v) and 50 mL of 100% acetonitrile will be added to the pellet, and mixed thoroughly after each reagent is added. The suspension will be centrifuged again at 13,000g for another 2 minutes, and 1 mL of the supernatant will be spotted onto the steel target plate. Analysis will be performed following air-drying of 1 mL a-cyano-4-hydroxycinnamic acid matrix solution placed onto the dried sample spot in duplicate. Mass spectra profiles will be acquired using a microflex LT MALDI-TOF mass spectrometer (Bruker Daltonics, Bremen, Germany) following the manufacturer's settings. Spectra will be recorded in the linear positive mode at a laser frequency of 60 Hz within a mass range from 2000 Da to 20,000 Da. All bacteria identifications will be performed by MALDI-TOF Biotyper RTC and the Bruker MALDI Biotyper 3.1 software and library (4613 isolates; Bruker Daltonics). Criteria used for microorganism analysis and identification will be as recommended by the manufacturer.
- Statistical analysis Time to identification will be determined as the time from colony formation to the time at which the final result is reported to a physician. Statistical analysis will be performed to compare the three methods using Chi-square tests. The level of statistical significance will be set at p < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PJI | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The synovial joint fluid will be sampled before the arthrotomy at the operation room. Aspirates will be collected under an aseptic technique with an 18-Fr sterile syringe with a minimum amount of 14 cc. The sample was partitioned between two set of aerobic and anaerobic BCBs (at least 2.5cc for each bottle), wound culture tube (2cc), synovial fluid analysis (2cc). In instances where there is insufficient fluid to send all 3 modalities (less than 14 mL), patients will be excluded from the current investigation. Samples will be delivered to the clinical microbiology laboratory within a 2-hour period.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients not meeting MSIS criteria
- Patients undergoing aseptic revision
- Insufficient synovial fluid amount for analysis.
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 |
|---|---|---|
| No interventionSample collection study Sample collection and collection of laboratory values | Other | Patients with PJI |
Primary outcome
The identification rate of microorganisms
Time frame: Immediate post-operative period (usually within 5-7 days following surgery)
The organism identification from direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures
1 secondary outcome
The timing of organism identification
Time frame: Immediate post-operative period (usually within 5-7 days following surgery)
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 28 Aug 2019.
- Background: PubMed 11716377Peersman G, Laskin R, Davis J, Peterson M. Infection in total knee replacement: a retrospective review of 6489 total knee replacements. Clin Orthop Relat Res. 2001 Nov;(392):15-23.
- Background: PubMed 18591595Fink B, Makowiak C, Fuerst M, Berger I, Schafer P, Frommelt L. The value of synovial biopsy, joint aspiration and C-reactive protein in the diagnosis of late peri-prosthetic infection of total knee replacements. J Bone Joint Surg Br. 2008 Jul;90(7):874-8. doi: 10.1302/0301-620X.90B7.20417.
- Background: PubMed 27020677Geller JA, MacCallum KP, Murtaugh TS, Patrick DA Jr, Liabaud B, Jonna VK. Prospective Comparison of Blood Culture Bottles and Conventional Swabs for Microbial Identification of Suspected Periprosthetic Joint Infection. J Arthroplasty. 2016 Aug;31(8):1779-83. doi: 10.1016/j.arth.2016.02.014. Epub 2016 Feb 24.
- Background: PubMed 26733067Peel TN, Dylla BL, Hughes JG, Lynch DT, Greenwood-Quaintance KE, Cheng AC, Mandrekar JN, Patel R. Improved Diagnosis of Prosthetic Joint Infection by Culturing Periprosthetic Tissue Specimens in Blood Culture Bottles. mBio. 2016 Jan 5;7(1):e01776-15. doi: 10.1128/mBio.01776-15.
- Background: PubMed 22092265Croxatto A, Prod'hom G, Greub G. Applications of MALDI-TOF mass spectrometry in clinical diagnostic microbiology. FEMS Microbiol Rev. 2012 Mar;36(2):380-407. doi: 10.1111/j.1574-6976.2011.00298.x. Epub 2011 Aug 22.
- Background: PubMed 27503535Haiko J, Savolainen LE, Hilla R, Patari-Sampo A. Identification of urinary tract pathogens after 3-hours urine culture by MALDI-TOF mass spectrometry. J Microbiol Methods. 2016 Oct;129:81-84. doi: 10.1016/j.mimet.2016.08.006. Epub 2016 Aug 5.
- Individual participant dataSharing planned: Undecided
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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.
Feng-Chih Kuo, MD study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Joint Infection, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 0 inclusion and 3 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 28 Aug 2019. 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 Taiwan. 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?
The identification rate of microorganisms (time frame: Immediate post-operative period (usually within 5-7 days following surgery)). 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 NCT03717090, which also lists 6 linked publications.
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 28 Aug 2019.