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

Humeral Fracture Clinical Trial

— DELTOSUPEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03694457
• Other study ID #: CHU-410
• Secondary ID: 2018-A02113-52
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged Patient
• Fractures, Bone
• Humeral Fracture
• Humeral Fractures
• Reversed Total Shoulder Arthroplasty
• Surgical Approach

Intervention

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

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Radiologic evaluation	Radiologic evaluation	pre op, 3, 6 and 12 months
Secondary	Complications	list of the complications	pre op, 3, 6 and 12 months