Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure
NCT ID: NCT06724094
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2105 participants
OBSERVATIONAL
2025-08-31
2025-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Failed
This group will be made up of patient who had revision TKR due to aseptic loosening within 10 years of primary arthroplasty
No interventions assigned to this group
Well performing
This group will be made up of patients who have an asymptomatic TKR 10 years after primary arthroplasty.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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T&O0238
Identifier Type: -
Identifier Source: org_study_id
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