Rapid Diagnosis of Prosthetic Joint Infection by Matrix-assisted Laser Desorption

NCT03717090 | Completed

• 1 other identifier: CMRPG8F1402
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prosthetic Joint Infection

Keywords

mass spectrometry, diagnosis, prosthetic joint infection, matrix-assisted laser desorption ionization

Outcome Measures

Primary Outcomes (1)

• The identification rate of microorganisms

  The organism identification from direct identification of MALTI-TOF MS, routine identification of MALTI-TOF MS and conventional cultures

  Immediate post-operative period (usually within 5-7 days following surgery)

Secondary Outcomes (1)

• The timing of organism identification

  Immediate post-operative period (usually within 5-7 days following surgery)

Study Arms (1)

Patients with PJI

Other: No intervention

Interventions

No intervention OTHER

Sample collection study Sample collection and collection of laboratory values

Patients with PJI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may not qualify if:

• Patients not meeting MSIS criteria
• Patients undergoing aseptic revision
• Insufficient synovial fluid amount for analysis.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 11716377 BACKGROUND

• Fink 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.

  PMID: 18591595 BACKGROUND

• Geller 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.

  PMID: 27020677 BACKGROUND

• Peel 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.

  PMID: 26733067 BACKGROUND

• Croxatto 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.

  PMID: 22092265 BACKGROUND

• Haiko 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.

  PMID: 27503535 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng-Chih Kuo, MD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: December 1, 2016
• Primary Completion: May 30, 2019
• Study Completion: May 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

TW (1)