Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID

NCT05320354 | Unknown

• 1 other identifier: 22-072
• Study Type: observational
• Target: 200
• Locations: 6 countries
• Sites: 6

Brief Summary

The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.

Conditions

Periprosthetic Joint Infection; PJI

Keywords

Microbial-ID test; Periprosthetic joint infection

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the MID-test

  Sensitivity of the MID-test based upon the number of subjects with a positive MID-test AND ≥1 positive microbiology culture(s) for the same bacterial species (true positives) and the number of subjects with a negative MID-test AND ≥1 positive microbiology culture(s) for one of the four bacterial species the MID-test is testing for (false negatives).

  after 3 weeks

• Specificity of the MID-test

  Specificity of the MID-test based upon the number of subjects with a negative MIDtest AND only negative microbiology cultures (true negatives) and the number subjects with a positive MID-test AND only negative microbiology cultures (false positives).

  after 3 weeks

Secondary Outcomes (4)

• Comparison of MID-test and the MB culture(s) regarding the time-to-result.

  after 3 weeks

• Rate of identification of bacterial species by the MID-test and the corresponding MB culture(s).

  after 3 weeks

• Proportion of agreement between the MID-test and the diagnosis of PJI according to the EBJIS definition.

  after 3 weeks

• Rate of "false positives" in the reported low-grade PJIs at ≥1-year follow-up.

  after 1 year

Study Arms (1)

Patients suspected of PJI

Adult patients, both male and female, scheduled for a puncture or surgery of their prosthetic joint due to suspected PJI.

Diagnostic Test: Microbial ID test

Interventions

Microbial ID test DIAGNOSTIC_TEST

In addition to the standard of care procedure for patients suspected for a periprosthetic joint infection, the MID-test will be performed using the residual synovial fluid. Individual test results of the MID-test are not reported back to the participating sites in order to not interfere with the sites' standard of care approach.

Also known as: Synovasure® Microbial Identification Test, Synovasure® Microbial ID P. acnes Test.

Patients suspected of PJI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a potentially infected joint implant, who will undergo an articular puncture and/or surgery with harvesting of synovial fluid.

You may qualify if:

• Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical features for joint infection at physical examination (swelling, redness, warm, sinus tract) AND has an elevated serum CRP (\>10 mg/L)
• Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid
• Patient ≥ 18 years of age
• Patient is competent, able, and willing to provide written informed consent

You may not qualify if:

• Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;
• Other obvious reason(s) for implant dysfunction, such as: fracture, an implant breakage, a malposition, and/or a tumour.

Sponsors & Collaborators

• UMC Utrecht: lead
• Zimmer Biomet: collaborator

Study Sites (6)

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Location

Hospitalar do Porto,

Porto, Portugal

Location

Valdoltra Orthopeadic Hospital,

Valdoltra, Slovenia

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Universitätsspital Basel,

Basel, Switzerland

Location

Study Officials

• Harrie Weinans, Prof, MD

  H.H.Weinans@umcutrecht.nl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: April 25, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

NL (1); DE (1); PT (1); SL (1); ES (1); CH (1)