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

Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 &Amp; 4-Part Proximal Humerus Fractures: A Randomized Prospective Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02597972

Enrollment

Registered

2015-11-05

Start date

2015-09-30

Completion date

2018-12-17

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fracture Proximal Humerus, Four Part

Brief summary

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

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.

Interventions

PROCEDUREFracture repair

PROCEDUREFracture repair with joint replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion * 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.

Design outcomes

Primary

Measure	Time frame	Description
To measure the change using the chi-square tests for lowering the pain score of the patients	base line to 2 years	threshold of statistical significance will be set at α = 0.05.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026