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Using Metagenomic NGS technique for detecting pathogens of Prosthetic Joint Infection: a prospective multicenter study

Using Metagenomic NGS technique for detecting pathogens of Prosthetic Joint Infection: a prospective multicenter study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025683
Enrollment
Unknown
Registered
2019-09-05
Start date
2019-09-05
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

periprosthetic joint infection

Interventions

Gold Standard:Modified MSIS Criteria
Index test:The results of mNGS

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients with any suspicion of infection after totaljoint arthroplasty (including spacer), such as acute onset of pain or persistent pain since surgery; an increased erythrocyte sedimentation rate (ESR) and/or C-reactiveprotein (CRP) level; or implant failure within 5 years after primary arthroplasty without any reasonable explanation. 2) Patients who are to undergo DAIR or revision arthropalsty.

Exclusion criteria

Exclusion criteria: 1) Patients with other implants, such as a plate or screw in the joint rather than a prothesis; 2) Patients with severe diseases or other risk factors are not suitable for aspiration or hip/knee debridement /revision; 3) Failed aspiration (failed to aspirate any useful fluid, even with saline solution lavage); 3) Patients who were lost to follow-up after aspiration and had insufficient information to determine whether infection was present; 5) Refuse to participate this trial.

Design outcomes

Primary

MeasureTime frame
results of culture;results of mNGS;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
sinus tract;ESR;CRP;synovial WBC count;PMN%;LE strip test;frozen section;

Countries

China

Contacts

Public ContactWei Chai

Chinese PLA General Hospital

chaiwei301@163.com+86 13601372998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026