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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Reversed Total Shoulder Arthroplasty; Aged Patient; Surgical Approach; Humeral Fracture

Treatments: Procedure: lateral approach; Procedure: Reversed total shoulder arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03694457

CHU-410

2018-A02113-52 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

deltopectoral approach

Active Comparator group

Description:

the patients are treated with deltopectoral approach surgery

Treatment:

Procedure: Reversed total shoulder arthroplasty

lateral approach

Other group

Description:

the patients are treated with a lateral approach surgery

Treatment:

Procedure: lateral approach