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MERISCREEN Alpha Defensin Rapid Test is a qualitative screening, invitro diagnostic, immunochromatography assay for detecting Alpha Defensin antimicrobial peptides in synovial fluid, produced in response to periprosthetic joint infection in humans.

MERISCREEN Alpha Defensin Rapid Test: Evaluation of the diagnostic performance of the MERISCREEN Alpha Defensin Rapid Test in detecting synovial infection. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097617
Enrollment
117
Registered
2025-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: M971- Periprosthetic fracture around internal prosthetic knee joint

Interventions

Intervention1: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt. Ltd,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants aged 18 years or older, regardless of gender. 2. Participants who will undergo in-vitro diagnostic immuno-chromatography assay using the MERISCREEN Alpha Defensin Rapid Test. 3. Participants will have all of the medical tests required to allow the MSIS classification. 4. Participants with suspected prosthetic joint infection based on clinical manifestations- fever, joint pain, fistula redness, swelling, hotness and loss of function with supportive radiological evidence. 5. Participants with a painful or failed joint arthroplasty with suspected infection and clinical manifestations mentioned above. 6. Participants must agree not to participate in any other trial or invasive study for 6 months. 7. Participants who are able to give voluntary, written informed consent to participate in this clinical trial and from whom consent has been obtained.

Exclusion criteria

Exclusion criteria: 1. Aspirations from native joints (not with a prosthetic joint). 2. Aspirations from spacers/temporary implants impregnated with antibiotics. 3. Participants with a major joint trauma (such as a documented ligament tear or fracture) within the past 4 weeks who are not eligible to have that joint aspirated 4. Participants who are unwilling or unable to sign the Informed Consent Document.

Design outcomes

Primary

MeasureTime frame
1. Diagnostic accuracy- Sensitivity. Timepoint: 1. Time Frame: Aspiration day/Base Line—

Secondary

MeasureTime frame
1. Positive Predictive Value or Negative Predictive Value. 2. Accuracy. 3. Ease of handling on-site rapid use.Timepoint: 1. Time Frame: Aspiration day and 3-Month ± 10 days. 2. Time Frame: Aspiration day and 3-Month ± 10 days. 3. Time Frame: Aspiration day—

Countries

India

Contacts

Public ContactDr Kiran Kumar Shetty

Meril LIfe Science Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026