AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES

NCT ID: NCT06467006

Last Updated: 2024-06-20

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2027-09-30

Brief Summary

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Our smartphones can recognize the pictures of our family, loved ones and friends. Face recognition software leverages artificial intelligence (AI), image recognition and other advanced technology to map, analyze and confirm the identity of a face.

We humans do a poor job when classifying the injury related to a patient sustaining a proximal humeral fracture. In consequence, there is great heterogeneity in the treatment of proximal humerus fractures. Moreover, offering relevant information to patients regarding the risk of complications or fracture sequelae is challenging, given that the current series are based on obsolete classifications, and the published series bring together just over hundreds of patients analyzed. With these limitations, patients have few opportunities to participate in decision-making about their injury.

The present project aim is to integrate new technologies for the prediction of relevant clinical results for the patients presenting a proximal humeral fracture. In brief, AI can help identify similar fracture patterns without human inference, while humans can feed the algorithm with variables of interest such as the functional outcomes and complications related to this particular type of fracture.

Detailed Description

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Conditions

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Proximal Humeral Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Use of IA for proximal humeral fracture prognosis

None (prognosis study)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients sustaining a proximal humerus fracture treated nonoperatively under the criteria of the treating surgeon and patients' preference.

Subjects evaluated within the first 3 weeks after the injury. Patients between 18 and 90 years of age. Patients who have been studied with simple shoulder radiographs in anteroposterior and scapular outlet projections.

Participants who accept 1-year time follow-up.

Exclusion Criteria

Patients with dementia or difficulty completing the evaluation after one year of follow-up.

Patients who have previously received surgical treatment on the affected limb. Patients who have suffered a previous fracture in the affected limb. Surgically treated patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role collaborator

Parc TaulĂ­ Hospital Universitari

OTHER

Sponsor Role collaborator

Consorci Sanitari de l'Anoia

OTHER

Sponsor Role lead

Responsible Party

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Joan Miquel

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2024/5001

Identifier Type: -

Identifier Source: org_study_id

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