Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 2, 2018

Estimated Primary Completion Date

November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Constant Murley Score[ Time Frame: 12 months ]

Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Quick dash score[ Time Frame: 3, 6 and 12 months ]
the Quick Dash score is a functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
SF12 score[ Time Frame: 3, 6 and 12 months ]
The SF12 score is a quality of life assessment. The score varies between 0 and 100, more the value is better brought up is the score
Alder score[ Time Frame: 3, 6 and 12 months ]
Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
The Simple Shoulder Test (SST)[ Time Frame: 3, 6 and 12 months ]
The Simple Shoulder Test is functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
WOOS (The Western Ontario Osteosarthritis )[ Time Frame: 3, 6 and 12 months ]
The Western Ontario Osteosarthritis of the shoulder index is a quality of life measurement tool for osteoarthritis of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
intensity of pain[ Time Frame: pre op, 3, 6 and 12 months ]
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Radiologic evaluation[ Time Frame: pre op, 3, 6 and 12 months ]
Radiologic evaluation
Complications[ Time Frame: pre op, 3, 6 and 12 months ]
list of the complications

Descriptive Information

Brief Title ^ICMJE

Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

Official Title ^ICMJE

Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

Brief Summary

The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

Detailed Description

The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18). Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty. The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:no masking
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Reversed total shoulder arthroplasty
Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
Procedure: lateral approach
Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach

Study Arms

Active Comparator: deltopectoral approach
the patients are treated with deltopectoral approach surgery
Other: lateral approach
the patients are treated with a lateral approach surgery

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2021

Estimated Primary Completion Date

November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated) - Patient registered to the national health system - Patient able to understand information about the protocol and answer to questionnaire Exclusion Criteria: - Non-displaced fracture or no need of surgical treatment. - Existing bone disease - Infection - Neurological deficit (axillary nerve) - Multi-injured patients - Patient no able to fulfill the questionnaire - Patient refuses the study

Sex/Gender

Sexes Eligible for Study:

All

Ages

65 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Guillaume VILLATTE University Hospital, Clermont-Ferrand

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名