New Molecular Approaches for Diagnosis of Prosthetic Joint Infection

NCT06670885 | Enrolling By Invitation

• 2 other identifiers: MerianL2071
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this observational study are:

1. 1.to evaluate the concordance between traditional method (culture) and genomic method in diagnosing prosthetic joint infections;
2. 2.to define an algorithm for laboratory diagnosis of prosthetic joint infections, which could be easily applied in our hospital setting;
3. 3.to test different DNA extraction protocols to obtain high yields of microbial nucleic acids from infected human tissue samples.

Conditions

Prosthetic Joint Infection

Keywords

Diagnosis of prosthetic joint infections; molecular methods

Outcome Measures

Primary Outcomes (1)

• Concordance between analytical methods

  Concordance between methods will be analyzed by 1. Patient categorization (Infected/not infected) 2. Microorganisms identification

  24 months

Secondary Outcomes (1)

• Definition of an algorithm for laboratory diagnosis of prosthetic joint infections

  36 months

Other Outcomes (1)

• Comparison of different protocols for microbial DNA extraction

  18 months

Study Arms (3)

Group A

Patients with diagnosis of infection confirmed by culture results

Group B

Patients with diagnosis of prosthetic joint infection according to criteria of the MusculoSkeletal Infection Society (MSIS) but with negative culture

Group C

Patients with no evidence of prosthetic joint infection according to criteria of MusculoSkeletal Infection Society (MSIS) (negative controls)

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

A total of 70 patients from the Department of Reconstructive Surgery and Osteoarticular Infections (CRIO) and the Hip Units of IRCCS Ospedale Galeazzi -Sant'Ambrogio for suspected infection of their prosthesis will be enrolled in the study.

You may qualify if:

• Age \>18 years
• Males and females
• Patients with a clinical indication for knee and hip revision surgery admitted at IRCCS Ospedale Galeazzi - Sant'Ambrogio

You may not qualify if:

• Insufficient amount of periprosthetic tissue and synovial fluid collected
• Patients unable to sign the Informed Consent
• Pregnancy and breast feeding with declaration of patient
• Age \<18 years

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milano, 20157, Italy

Location

Related Publications (7)

• Kullar R, Chisari E, Snyder J, Cooper C, Parvizi J, Sniffen J. Next-Generation Sequencing Supports Targeted Antibiotic Treatment for Culture Negative Orthopedic Infections. Clin Infect Dis. 2023 Jan 13;76(2):359-364. doi: 10.1093/cid/ciac733.

  PMID: 36074890 BACKGROUND

• Tsikopoulos K, Meroni G. Periprosthetic Joint Infection Diagnosis: A Narrative Review. Antibiotics (Basel). 2023 Sep 27;12(10):1485. doi: 10.3390/antibiotics12101485.

  PMID: 37887186 BACKGROUND

• Salar-Vidal L, Chaves C, Dianzo-Delgado IT, Favier P, Giner-Almaraz S, Gomez-Gomez MJ, Martin-Gutierrez G, Pereira I, Rodriguez-Fernandez A, Ruiz-Garbajosa P, Salas-Venero C, Esteban J. Multicenter evaluation of BioFire JI panel related to improved microbiological diagnostics on acute osteoarticular infections. Int J Med Microbiol. 2023 Nov;313(6):151588. doi: 10.1016/j.ijmm.2023.151588. Epub 2023 Oct 31.

  PMID: 37925748 BACKGROUND

• Villa F, Toscano M, De Vecchi E, Bortolin M, Drago L. Reliability of a multiplex PCR system for diagnosis of early and late prosthetic joint infections before and after broth enrichment. Int J Med Microbiol. 2017 Sep;307(6):363-370. doi: 10.1016/j.ijmm.2017.07.005. Epub 2017 Jul 18.

  PMID: 28750797 BACKGROUND

• Mortazavi SM, Schwartzenberger J, Austin MS, Purtill JJ, Parvizi J. Revision total knee arthroplasty infection: incidence and predictors. Clin Orthop Relat Res. 2010 Aug;468(8):2052-9. doi: 10.1007/s11999-010-1308-6.

  PMID: 20309657 BACKGROUND

• Tan TL, Kheir MM, Shohat N, Tan DD, Kheir M, Chen C, Parvizi J. Culture-Negative Periprosthetic Joint Infection: An Update on What to Expect. JB JS Open Access. 2018 Jul 12;3(3):e0060. doi: 10.2106/JBJS.OA.17.00060. eCollection 2018 Sep 25.

  PMID: 30533595 BACKGROUND

• Murphy MP, MacConnell AE, Killen CJ, Schmitt DR, Wu K, Hopkinson WJ, Brown NM. Prevention Techniques Have Had Minimal Impact on the Population Rate of Prosthetic Joint Infection for Primary Total Hip and Knee Arthroplasty: A National Database Study. J Arthroplasty. 2023 Jun;38(6):1131-1140. doi: 10.1016/j.arth.2023.02.059. Epub 2023 Feb 27.

  PMID: 36858132 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be avalable form the end of the study

Locations

IT (1)