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Research on the Application Value of Point-of-Care Calprotectin Test Strip in the Diagnosis of Periprosthetic Joint Infection

Research on the Application Value of Point-of-Care Calprotectin Test Strip in the Diagnosis of Periprosthetic Joint Infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127524
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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:The internationally recognized diagnostic criteria for periprosthetic joint infection (PJI), namely the 2018 International Consensus Meeting (ICM) criteria and/or the 2021 European Bone
Index test:Lyfstone Calprotectin Lateral Flow Test

Sponsors

Chinese PLA General Hospital Fourth Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged >=18 years, of either sex; patients scheduled for hip or knee revision arthroplasty for any reason (including single-stage revision, one-stage or two-stage revision, and debridement, antibiotics, and implant retention [DAIR] procedures); availability of an adequate synovial fluid sample (>=1 mL) obtained preoperatively or intraoperatively for calprotectin testing and routine synovial fluid analysis; and provision of written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: **Exclusion criteria:** Patients who have received systemic antibiotics within 2 weeks prior to surgery (excluding perioperative prophylactic antibiotics); patients with active inflammatory arthropathies involving the target joint (such as rheumatoid arthritis, gouty arthritis, or psoriatic arthritis); patients with traumatic joint infections; patients who refuse joint aspiration; patients in whom joint aspiration has failed, including those in whom no synovial fluid is obtained or only inadequate/invalid synovial fluid is collected (e.g., contaminated or insufficient volume for diagnostic analysis); patients who have undergone joint aspiration or surgical intervention on the target joint within the past 3 months (excluding diagnostic aspiration); and any other conditions deemed inappropriate for inclusion by the investigators.

Design outcomes

Primary

MeasureTime frame
Synovial fluid calprotectin test results ;Diagnostic accuracy for periprosthetic joint infection (PJI);

Countries

China

Contacts

Public ContactZhang Guoqiang

Chinese PLA General Hospital Fourth Medical Center

gqzhang301@163.com+86 136 0121 0743

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026