Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures

NCT ID: NCT02597972

Last Updated: 2020-01-27

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

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-17

Brief Summary

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Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?

Detailed Description

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The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.

Conditions

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Closed Fracture Proximal Humerus, Four Part

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Reduction Internal Fixation Proximal Humerus

The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate.

Group Type ACTIVE_COMPARATOR

Fracture repair

Intervention Type PROCEDURE

Reverse Total Shoulder Arthroplasty

The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty.

Group Type ACTIVE_COMPARATOR

Fracture repair with joint replacement

Intervention Type PROCEDURE

Interventions

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Fracture repair

Intervention Type PROCEDURE

Fracture repair with joint replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Neer 3 and 4-part proximal humerus fractures.
* Age greater than and equal to 70 years old.
* Functional deltoid musculature (axillary nerve intact).

Exclusion

* Less than 70 years old.
* Dementia or inability to provide adequate follow up.
* Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Joaquin Sanchez-Sotelo, M.D., Ph.D.

Professor of Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joaquin Sanchez-Sotelo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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15-004148

Identifier Type: -

Identifier Source: org_study_id

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