Study on Outcomes of Proximal Humerus Fractures

NCT ID: NCT07060664

Last Updated: 2025-10-17

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-01

Study Completion Date

2028-07-01

Brief Summary

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Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.

Detailed Description

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Conditions

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Proximal Humerus Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operative Management

Group Type ACTIVE_COMPARATOR

open reduction internal fixation

Intervention Type PROCEDURE

treatment with open reduction and plates/screws

intramedullary nail

Intervention Type PROCEDURE

open reduction and intramedullary nail

reverse total shoulder arthroplasty

Intervention Type PROCEDURE

reverse total shoulder arthroplasty

Non-operative Management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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open reduction internal fixation

treatment with open reduction and plates/screws

Intervention Type PROCEDURE

intramedullary nail

open reduction and intramedullary nail

Intervention Type PROCEDURE

reverse total shoulder arthroplasty

reverse total shoulder arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

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ORIF IMN RTSA

Eligibility Criteria

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Inclusion Criteria

* individuals 65 years of age or older with proximal humerus fractures

Exclusion Criteria

\-
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Gregory Iovanel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne Chan, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

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UMass Chan Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Gregory Iovanel, MD

Role: CONTACT

401-651-8188

Facility Contacts

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Gregory Iovanel, MD

Role: primary

401-651-8188

Other Identifiers

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00002567

Identifier Type: -

Identifier Source: org_study_id

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