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

NCT03646253 | Completed

• 1 other identifier: 2017Ao005
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reproducibility; Four Part Fracture; Proximal Humerus Fracture; Hertel's Criteria

Keywords

Proximal humerus fracture

Outcome Measures

Primary Outcomes (8)

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

  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.

  Day 0

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

  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.

  Day 0

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

  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.

  Day 0

• Inter-rater reproducibility concerning calcar comminution for 3D reconstructions

  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.

  Day 0

• Inter-rater reproducibility concerning medial hinge for 3D reconstructions

  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.

  Day 0

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

  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.

  Day 0

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

  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.

  Day 0

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

  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.

  Day 0

Study Arms (1)

Patients with proximal humerus fracture

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

Interventions

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

Patients with proximal humerus fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

• Ohl X, Mangin P, Barbe C, Brun V, Nerot C, Sirveaux F. Analysis of four-fragment fractures of the proximal humerus: the interest of 2D and 3D imagery and inter- and intra-observer reproducibility. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):295-299. doi: 10.1007/s00590-017-1911-2. Epub 2017 Jan 24.

  PMID: 28120098 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 24, 2018
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

FR (1)