NCT05804058

Brief Summary

Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee prostheses, with an incidence of around 1-2%. Infection can occur early (within days of surgery) or late (over a year after surgery), and no specific early markers for infection onset exist. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risk to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a more specific predictive test for early onset of infection is required.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2021

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

August 16, 2019

Last Update Submit

April 6, 2023

Conditions

Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Characteristic Formation of bacterial biofilm on orthopaedic implants

    measured by infection assessment- this is the term for the measure

    1 day study visit

Study Arms (1)

Orthopaedic Patients

Patients due to undergo prosthetic hip revision surgery

Procedure: Revision surgery

Interventions

Revision surgeryPROCEDURE

Patients due to undergo prosthetic revision surgery for any reason (infection or aseptic)

Orthopaedic Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting with symptoms likely to require revision hip surgery for correction.

You may qualify if:

  • Male or Female, aged 18 years or above.
  • Due to undergo prosthetic revision surgery for any reason identified by the clinical team Willing to provide informed consent

You may not qualify if:

  • Participant lacking capacity to give informed consent
  • Any other clinical reason the participant should not be included in the study- at the discretion of the clinical team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Synovial Fluid

MeSH Terms

Interventions

Reoperation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

April 7, 2023

Study Start

July 1, 2019

Primary Completion

January 19, 2021

Study Completion

January 19, 2021

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)