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Completed

NCT Number: NCT03694457

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

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.

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Key information

Conditions

Humeral Fracture Aged Patient Arm Injuries Fractures, Bone Humeral Fractures Reversed Total Shoulder Arthroplasty Surgical Approach Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reversed total shoulder arthroplasty

Procedure

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

lateral approach

Procedure

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

Primary outcomes

  1. Constant Murley Score

    Time frame: 12 months

    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

Secondary outcomes

  1. Quick dash score

    Time frame: 3, 6 and 12 months

    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

  2. SF12 score

    Time frame: 3, 6 and 12 months

    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. Alder score

    Time frame: 3, 6 and 12 months

    Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score

  4. The Simple Shoulder Test (SST)

    Time frame: 3, 6 and 12 months

    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

  5. WOOS (The Western Ontario Osteosarthritis )

    Time frame: 3, 6 and 12 months

    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

  6. intensity of pain

    Time frame: pre op, 3, 6 and 12 months

    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)

  7. Radiologic evaluation

    Time frame: pre op, 3, 6 and 12 months

    Radiologic evaluation

  8. Complications

    Time frame: pre op, 3, 6 and 12 months

    list of the complications

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: DELTOSUPEX

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Oct 3, 2018
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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