NCT02597972

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)?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.3 years

First QC Date

September 17, 2015

Last Update Submit

January 22, 2020

Conditions

Closed Fracture Proximal Humerus, Four Part

Outcome Measures

Primary Outcomes (1)

  • 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 α = 0.05.

    base line to 2 years

Study Arms (2)

Open Reduction Internal Fixation Proximal Humerus

ACTIVE COMPARATOR

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

Reverse Total Shoulder Arthroplasty

ACTIVE COMPARATOR

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

Interventions

Fracture repairPROCEDURE
Open Reduction Internal Fixation Proximal Humerus
Fracture repair with joint replacementPROCEDURE
Reverse Total Shoulder Arthroplasty

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Arthroplasty, Replacement

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Joaquin Sanchez-Sotelo, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedics

Study Record Dates

First Submitted

September 17, 2015

First Posted

November 5, 2015

Study Start

September 1, 2015

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

US(1)