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NCT Number: NCT03646253

Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility

Fractures of the proximal humerus are increasingly frequent, with numbers tripling between the 1970s and the 2000s. Among these fractures, those involving the tuberosities and also the anatomic neck are a therapeutic challenge. For this type of fracture (Neer's four-part fracture) the degree of displacement of the fracture needs to be understood in order to provide suitable treatment and apprehend the risks in its evolution. There is indeed, in this type of fracture, a risk of humeral head ischaemia, which will carry considerable weight in the therapy adopted.

The usual classifications, such as the AO or the Neer classification, have shown their limitations in terms of reproducibility and are not suitable for the prognostic assessment of these four-fragment fractures of the proximal humerus. The radiographic parameters described by Hertel in 2004, on the other hand, seem to be far more relevant to routine clinical practice.

The use of the scanner to improve reproducibility of the classification of these proximal humerus fractures is still controversial. The scanner is the rule to guide therapeutic strategy for complex fractures, although the reproducibility of the different assessment criteria has never been studied.

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Key information

Conditions

Reproducibility Four Part Fracture Hertel's Criteria Proximal Humerus Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Damien JOLLY

Reims, France

About this study

The aims of the present study were firstly to analyse inter-observer and intra-observer reproducibility for the different criteria proposed by Hertel, using three types of imagery (standard radiographies, 2D and 3D scans) and secondly to assess the relevance of the use of the scanner to improve reproducibility

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Proximal humerus fracture
  • standard radiographs, a 2D scan with axial, sagittal and coronal sections, and high-resolution 3D reconstructions performed in emergency settings when the patient arrived in the care facility

Treatment and study plan

Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)

Other

Primary outcomes

  1. Inter-rater reproducibility concerning displacement of the humeral head on the frontal plane for 3D reconstructions

    Time frame: Day 0

    Displacement of the humeral head on the frontal plane evaluated in "not displaced", "varus" or "valgus".

    Assessment of inter-rater reproductibility for displacement of the humeral head on the frontal plane using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  2. Inter-rater reproducibility concerning displacement of the humeral head on the sagittal plane for 3D reconstructions

    Time frame: Day 0

    Displacement of the humeral head on the sagittal plane evaluated in "not displaced", "angle more than 20 degrees" or "angle less than 20 degrees".

    Assessment of inter-rater reproductibility for displacement of the humeral head on the sagittal plane using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  3. Inter-rater reproducibility concerning humeral head split for 3D reconstructions

    Time frame: Day 0

    Humeral head split evaluated in "presence" or "absence". Assessment of inter-rater reproductibility for humeral head split using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  4. Inter-rater reproducibility concerning calcar comminution for 3D reconstructions

    Time frame: Day 0

    Calcar comminution evaluated in "presence" or "absence". Assessment of inter-rater reproductibility for calcar comminution using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  5. Inter-rater reproducibility concerning medial hinge for 3D reconstructions

    Time frame: Day 0

    Medial hinge evaluated in "presence" or "absence". Assessment of inter-rater reproductibility for medial hinge using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  6. Inter-rater reproducibility concerning length of metaphyseal extension for 3D reconstructions

    Time frame: Day 0

    Length of metaphyseal extension evaluated in "less than 8 mm" or "more than 8 mm".

    Assessment of inter-rater reproductibility for length of metaphyseal extension using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  7. Inter-rater reproducibility concerning displacement of the greater tuberosity for 3D reconstructions

    Time frame: Day 0

    Displacement of the greater tuberosity evaluated in "not displaced", "more than 5 mm" or "less than 5 mm".

    Assessment of inter-rater reproductibility for displacement of the greater tuberosity using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

  8. Inter-rater reproducibility concerning displacement of the lesser tuberosity for 3D reconstructions

    Time frame: Day 0

    Displacement of the lesser tuberosity evaluated in "not displaced", "more than 5 mm" or "less than 5 mm".

    Assessment of inter-rater reproductibility for displacement of the lesser tuberosity using Cohen's Kappa coefficient. A Kappa coefficient comprised between 0.00 and 0.20 significate a very poor agreement, between 0.21 and 0.40 significate a poor agreement, between 0.41 and 0.60 significate a moderate agreement, between 0.61 and 0.80 significate a satisfactory agreement and between 0.81 and 1.00 significate an excellent agreement.

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: REPROD-HUMERUS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2018
Registry last updated
Aug 24, 2018

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

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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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