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NCT Number: NCT06724094

Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure

The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.

Researchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.

The algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.

The population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.

Failure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.

Well performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Had a NexGen TKR between 2003 and 2022.

Exclusion criteria

  • Below 18 yrs old.
  • Revision surgery for any reason other than aseptic loosening
  • patients who have not had a revision but who do not have a well functioning TKR.

Treatment and study plan

Primary outcomes

  1. Predictive accuracy of machine learning model

    Time frame: Up to 21 years. Data starts from 2003.

    The predictive accuracy of a machine learning algorithm. Using common ML measured, AUROC etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Rory Ormiston

CONTACT

[email protected]

07443 432819

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Registry information

Official study title

Using Machine Learning to Detect and Predict Loosening NexGen Total Knee Replacement

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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