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

Mayo Clinic

Status: Terminated

Conditions: Closed Fracture Proximal Humerus, Four Part

Treatments: Procedure: Fracture repair; Procedure: Fracture repair with joint replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT02597972

15-004148

Details and patient eligibility

About

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)?

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Open Reduction Internal Fixation Proximal Humerus

Active Comparator group

Description:

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

Treatment:

Procedure: Fracture repair

Reverse Total Shoulder Arthroplasty

Active Comparator group

Description:

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

Treatment:

Procedure: Fracture repair with joint replacement