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

NCT03694457 | Completed

• 2 other identifiers: CHU-4102018-A02113-52
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prospective; Randomized study; Proximal humerus fracture; Surgical treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quick dash score

  3, 6 and 12 months

• SF12 score

  3, 6 and 12 months

• Alder score

  3, 6 and 12 months

• The Simple Shoulder Test (SST)

  3, 6 and 12 months

• WOOS (The Western Ontario Osteosarthritis )

  3, 6 and 12 months

Study Arms (2)

deltopectoral approach

ACTIVE COMPARATOR

the patients are treated with deltopectoral approach surgery

Procedure: Reversed total shoulder arthroplasty

lateral approach

OTHER

the patients are treated with a lateral approach surgery

Procedure: lateral approach

Interventions

Reversed total shoulder arthroplasty PROCEDURE

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

deltopectoral approach

lateral approach PROCEDURE

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

lateral approach

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Guillaume VILLATTE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: November 26, 2018
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)