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

Primary Purpose

Humeral Fracture, Aged Patient, Reversed Total Shoulder Arthroplasty

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Reversed total shoulder arthroplasty

lateral approach

About this trial

This is an interventional treatment trial for Humeral Fracture focused on measuring Prospective, Randomized study, Proximal humerus fracture, Surgical treatment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chu Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

deltopectoral approach

lateral approach

Arm Description

the patients are treated with deltopectoral approach surgery

the patients are treated with a lateral approach surgery

Outcomes

Primary Outcome Measures

Constant Murley Score

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

Secondary Outcome Measures

Quick dash score

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

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

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)

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 )

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

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

Complications

list of the complications

Full Information

NCT ID

NCT03694457

First Posted

October 1, 2018

Last Updated

March 14, 2022

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT03694457

Brief Title

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

Acronym

DELTOSUPEX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Humeral Fracture, Aged Patient, Reversed Total Shoulder Arthroplasty, Surgical Approach

Keywords

Prospective, Randomized study, Proximal humerus fracture, Surgical treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

no masking

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

deltopectoral approach

Arm Type

Active Comparator

Arm Description

the patients are treated with deltopectoral approach surgery

Arm Title

lateral approach

Arm Type

Other

Arm Description

the patients are treated with a lateral approach surgery

Intervention Type

Procedure

Intervention Name(s)

Reversed total shoulder arthroplasty

Intervention Description

Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach

Intervention Type

Procedure

Intervention Name(s)

lateral approach

Intervention Description

Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach

Primary Outcome Measure Information:

Title

Constant Murley Score

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Quick dash score

Description

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

Time Frame

3, 6 and 12 months

Title

SF12 score

Description

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

Time Frame

3, 6 and 12 months

Title

Alder score

Description

Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score

Time Frame

3, 6 and 12 months

Title

The Simple Shoulder Test (SST)

Description

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

Time Frame

3, 6 and 12 months

Title

WOOS (The Western Ontario Osteosarthritis )

Description

Time Frame

3, 6 and 12 months

Title

intensity of pain

Description

Time Frame

pre op, 3, 6 and 12 months

Title

Radiologic evaluation

Description

Radiologic evaluation

Time Frame

pre op, 3, 6 and 12 months

Title

Complications

Description

list of the complications

Time Frame

pre op, 3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lise LACLAUTRE

Phone

04 73 75 49 63

drci@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillaume VILLATTE

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lise LACLAUTRE

Phone

04 73 75 49 63

drci@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Guillaume VILLATTE

12. IPD Sharing Statement

Citations:

PubMed Identifier

35727196

Citation

Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Results Reference

derived

Learn more about this trial

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

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