NCT06268795

Brief Summary

The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Mar 2024Sep 2028

First Submitted

Initial submission to the registry

February 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

4.5 years

First QC Date

February 12, 2024

Last Update Submit

July 23, 2025

Conditions

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Comparison of diagnostic accuracy

    Compare the diagnostic accuracy of percutaneous aspiration against the gold standard of open biopsy with multiple tissue samples

    36 months

Secondary Outcomes (1)

  • Culture analysis

    14 days

Eligibility Criteria

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

All patients that are 18 years or older that have been referred for potential revisions of the shoulder and elbow arthroplasty.

You may qualify if:

  • Aged: 18 years or older.
  • A participant is willing and able to give informed consent for participation in the study.
  • Patient undergoing revision shoulder or elbow arthroplasty surgery.
  • Previous anatomic total shoulder arthroplasty (TSA), shoulder hemiarthroplasty (HA), reverse total shoulder arthroplasty (RTSA), total elbow arthroplasty (TEA), distal humeral hemiarthroplasty (DHH) and radial head arthroplasty (RHA).

You may not qualify if:

  • Refusal of consent.
  • Antibiotic treatment was not stopped 2 weeks before aspiration or biopsy.
  • Pregnancy.
  • Part of any other trial with similar interventions unless previously agreed on with investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, Lancashire, WN6 9EP, United Kingdom

RECRUITING

Central Study Contacts

Adam Watts

CONTACT

01257 256259adam.c.watts@wwl.nhs.uk

Zaid Hamoodi

CONTACT

07533704775zaid.hamoodi@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

GB(1)