Clinical trial NCT03646253: Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility
Official title: Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproducibility
Four Part Fracture
Proximal Humerus Fracture
Hertel's Criteria
Keywords: Proximal humerus fracture
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Inter-rater reproducibility concerning displacement of the humeral head on the frontal plane for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning displacement of the humeral head on the sagittal plane for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning humeral head split for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning calcar comminution for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning medial hinge for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning length of metaphyseal extension for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning displacement of the greater tuberosity for 3D reconstructions
timeFrame: Day 0
measure: Inter-rater reproducibility concerning displacement of the lesser tuberosity for 3D reconstructions
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: 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.