AIortho: Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection

Sponsor
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04746001
Collaborator
Keele University (Other)
100
1
36.1
2.8

Study Details

Study Description

Brief Summary

Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Genomic sequencing
  • Diagnostic Test: Histological examination

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection
Actual Study Start Date :
Jun 28, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Infection

Diagnostic Test: Genomic sequencing
Sequencing data

Diagnostic Test: Histological examination
Images for deep learning

Tumours

Diagnostic Test: Genomic sequencing
Sequencing data

Diagnostic Test: Histological examination
Images for deep learning

Outcome Measures

Primary Outcome Measures

  1. Sequencing data and identification [3 years]

    Identification of infection and tumours using sequencing data

  2. Histological slides and identification [3 years]

    Deep learning using histological images

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Suspected infection of bone tumour and biopsy taken for analysis

Exclusion Criteria:

Patient doesn't consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust Oswestry Shropsire United Kingdom SY10 7AG

Sponsors and Collaborators

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
  • Keele University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
ClinicalTrials.gov Identifier:
NCT04746001
Other Study ID Numbers:
  • 281854_47208_2021
First Posted:
Feb 9, 2021
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2021