NCT06467006

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Sep 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Sep 2024Sep 2027

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

June 14, 2024

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley Score

    Functional outcome

    1 year

Interventions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients sustaining proximal humeral fractures, nonoperatively treated

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

June 20, 2024

Record last verified: 2024-06