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NCT06467006 Clinical Trial

AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES

Proximal Humeral Fracture Clinical Trial

— Orthopredict  

Official title:
ARTIFICIAL INTELLIGENCE-BASED PREDICTION OF CLINICAL OUTCOMES IN PATIENTS SUSTAINING PROXIMAL HUMERAL FRACTURES

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06467006
Other study ID # 2024/5001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date September 2027

Study information
Verified date June 2024
Source Consorci Sanitari de l'Anoia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date September 2027
Est. primary completion date December 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Use of IA for proximal humeral fracture prognosis
None (prognosis study)

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Consorci Sanitari de l'Anoia Parc de Salut Mar, Parc Taulí Hospital Universitari

Outcome
Type Measure Description Time frame Safety issue
Primary Constant-Murley Score Functional outcome 1 year
See also
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