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Investigation of a novel new test to aid revision surgery following hip or knee replacement infection

Alpha defensin use in Periprosthetic Joint Infection revision surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN94873042
Enrollment
50
Registered
2017-10-24
Start date
2017-11-01
Completion date
Unknown
Last updated
2019-04-29

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

Conditions

Patients undergoing second stage revision surgery for previous periprosthetic joint infection (either hip or knee) previously proven with microbiology results Surgery Periprosthetic joint infection (either hip or knee)

Interventions

Patients undergoing a second stage revision surgery following periprosthetic joint infection of either hip or knee are identified by their direct care team. The participant is seen by

Sponsors

Newcastle-upon-Tyne Hospitals Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Undergoing second stage revision surgery following periprosthetic joint infection of either hip or knee 2. Previous periprosthetic joint infection proven with culture results 3. Aged over 18 years

Exclusion criteria

Exclusion criteria: 1. Patient unwilling to consent 2. Patient lacks capacity to consent 3. Patient unable to consent due to communication or language barrier 4. Surgeon unwilling to take intra-operative aspirate sample

Design outcomes

Primary

MeasureTime frame
Alpha defensin is measured using the Synovasure lateral flow assays at the time of the second stage revision surgery.

Secondary

MeasureTime frame
1. The correlation between alpha defensin results and the microbiology culture results is measured using the intra-operative Synovasure result and the final culture result from the intra-operative samples at approximately 5 days post-operatively (once enhanced culture results are available) 2. Variance in the accuracy of alpha defensin in showing effective clearance of a previously infected joint prosthesis according to different patient groups is measured using patient demographics collated from review of medical notes, results and xrays retrospectively from the time that the patient first presented with symptoms leading to the diagnosis of PJI up until their second stage revision surgery

Countries

United Kingdom

Outcome results

None listed

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