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

NCT ID: NCT03646253

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2016-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Reproducibility Four Part Fracture Proximal Humerus Fracture Hertel's Criteria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with proximal humerus fracture

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 28120098 (View on PubMed)

Other Identifiers

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2017Ao005

Identifier Type: -

Identifier Source: org_study_id

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