ReproducibilityREPROD-HUMERUSNCT03646253
Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility
An observational study of Reproducibility and Four Part Fracture, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reproducibility, Four Part Fracture, Proximal Humerus Fracture
- What is being tested?
- Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)
- Keywords
- Proximal humerus fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients with proximal humerus fracture | Not described Receives: Other: Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Jun 2016
- Primary completion1 Sep 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ReproducibilityStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646253
- Sponsor's protocol ID
- 2017Ao005
- Acronym
- REPROD-HUMERUS
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28120098
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility
- ClinicalTrials.gov ID
- NCT03646253
- Acronym / sponsor ID
- REPROD-HUMERUS / 2017Ao005
- Keywords
- Proximal humerus fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with proximal humerus fracture | – | Other: Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions) | Other | Patients with proximal humerus fracture |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 28120098Ohl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproducibility and Four Part Fracture, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reproducibility concerning displacement of the humeral head on the frontal plane for 3D reconstructions (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.