Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure

NCT06724094 | Not Yet Recruiting

• 1 other identifier: T&O0238
• Study Type: observational
• Target: 2,105
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aseptic Loosening of Prosthetic Joint

Outcome Measures

Primary Outcomes (1)

• Predictive accuracy of machine learning model

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

  Up to 21 years. Data starts from 2003.

Study Arms (2)

Failed

This group will be made up of patient who had revision TKR due to aseptic loosening within 10 years of primary arthroplasty

Well performing

This group will be made up of patients who have an asymptomatic TKR 10 years after primary arthroplasty.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Had a NexGen TKR between 2003 and 2022.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Central Study Contacts

Rory Ormiston

CONTACT

07443 432819; rory.ormiston@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: December 9, 2024
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2024-12