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Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06724094
Enrollment
2105
Registered
2024-12-09
Start date
2025-08-31
Completion date
2025-12-31
Last updated
2025-05-13

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

Conditions

Aseptic Loosening of Prosthetic Joint

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.

Interventions

None listed

Sponsors

University Hospital Southampton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Predictive accuracy of machine learning modelUp to 21 years. Data starts from 2003.The predictive accuracy of a machine learning algorithm. Using common ML measured, AUROC etc.

Contacts

Primary ContactRory Ormiston
rory.ormiston@uhs.nhs.uk07443 432819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026