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

NCT ID: NCT03694457

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Humeral Fracture Aged Patient Reversed Total Shoulder Arthroplasty Surgical Approach

Keywords

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Prospective Randomized study Proximal humerus fracture Surgical treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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deltopectoral approach

the patients are treated with deltopectoral approach surgery

Group Type ACTIVE_COMPARATOR

Reversed total shoulder arthroplasty

Intervention Type PROCEDURE

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

lateral approach

the patients are treated with a lateral approach surgery

Group Type OTHER

lateral approach

Intervention Type PROCEDURE

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

Interventions

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Reversed total shoulder arthroplasty

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

Intervention Type PROCEDURE

lateral approach

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume VILLATTE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35727196 (View on PubMed)

Other Identifiers

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2018-A02113-52

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-410

Identifier Type: -

Identifier Source: org_study_id