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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Approach; Humeral Fracture; Aged Patient; Reversed Total Shoulder Arthroplasty
• Intervention / Treatment: Procedure: Reversed total shoulder arthroplasty; Procedure: lateral approach

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: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: deltopectoral approach; the patients are treated with deltopectoral approach surgery	Procedure: Reversed total shoulder arthroplasty; Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
Other: lateral approach; the patients are treated with a lateral approach surgery	Procedure: lateral approach; Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3, 6 and 12 months
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	3, 6 and 12 months
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	3, 6 and 12 months
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	3, 6 and 12 months
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	3, 6 and 12 months
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)	pre op, 3, 6 and 12 months
Radiologic evaluation	Radiologic evaluation	pre op, 3, 6 and 12 months
Complications	list of the complications	pre op, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Guillaume VILLATTE, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Estimated): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prospective; Randomized study; Surgical treatment; Proximal humerus fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Humeral Fractures
• Other Study ID Numbers: CHU-410; 2018-A02113-52 (Other Identifier: 2018-A02113-52)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No