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

January 22, 2020 updated by: Joaquin Sanchez-Sotelo, M.D., Ph.D., Mayo Clinic

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

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)?

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Fracture repair
Active Comparator: 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.
Procedure: Fracture repair with joint replacement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Joaquin Sanchez-Sotelo, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 17, 2018

Study Completion (Actual)

December 17, 2018

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-004148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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