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

Closed Fracture Proximal Humerus, Four Part Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02597972
• Other study ID #: 15-004148
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 17, 2018

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Closed Fracture Proximal Humerus, Four Part
• Fractures, Bone
• Fractures, Closed
• Humeral Fractures

Intervention

Procedure:
• Fracture repair

• Fracture repair with joint replacement

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials