- ICH GCP
- US Clinical Trials Registry
- 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 (REPROD-HUMERUS)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Reims, France
- Damien JOLLY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with proximal humerus fracture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 0
|
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. |
Day 0
|
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.
|
Day 0
|
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.
|
Day 0
|
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.
|
Day 0
|
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. |
Day 0
|
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. |
Day 0
|
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. |
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017Ao005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proximal Humerus Fracture
-
Technische Universität DresdenActive, not recruitingProximal Humerus FractureGermany
-
University Hospital, AkershusRecruitingProximal Humerus Fracture | 2 Part FractureNorway
-
Aga Khan University Hospital, PakistanNot yet recruitingTrauma | Proximal Humerus Fracture
-
Ottawa Hospital Research InstituteTerminated
-
Hopital de l'Enfant-JesusUnknownFracture of Proximal HumerusCanada
-
Zimmer BiometNot yet recruitingWrist Fracture | Proximal Humerus FractureItaly
-
East Lancashire Hospitals NHS TrustRecruiting
-
Université de MontréalCentre de recherche du Centre hospitalier universitaire de Sherbrooke; Hopital...CompletedClosed Fracture Proximal Humerus, NeckCanada
-
Mayo ClinicTerminatedClosed Fracture Proximal Humerus, Four PartUnited States
-
Hannover Medical SchoolTraumastiftungRecruiting
Clinical Trials on Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)
-
National Cancer Institute (NCI)Children's Oncology GroupRecruitingMalignant Solid Neoplasm | Advanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Glioma | Recurrent Malignant Solid Neoplasm | Recurrent... and other conditionsUnited States, Puerto Rico, Australia
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingPancreatic Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Pancreatic Intraductal Papillary-Mucinous Neoplasm | Stage I Pancreatic Cancer AJCC v6 and v7 | Stage II Pancreatic Cancer AJCC v6 and v7United States, Canada, Israel, Belgium
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingNeurofibromatosis Type 1 | Metastatic Malignant Peripheral Nerve Sheath Tumor | Recurrent Malignant Peripheral Nerve Sheath TumorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingStage I Kidney Wilms Tumor | Stage II Kidney Wilms Tumor | Stage III Kidney Wilms TumorUnited States, Canada, Australia, New Zealand, Puerto Rico, Israel, Switzerland
-
National Cancer Institute (NCI)RecruitingStage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal AdenocarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingMalignant Glioma | Rhabdoid Tumor | Advanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Recurrent Ependymoma | Recurrent Ewing Sarcoma | Recurrent Hepatoblastoma | Recurrent Langerhans Cell Histiocytosis | Recurrent Malignant Germ Cell Tumor | Recurrent Malignant Solid Neoplasm | Recurrent... and other conditionsUnited States, Puerto Rico, Australia, Canada
-
Children's Oncology GroupNot yet recruitingStage I Kidney Wilms Tumor | Stage II Kidney Wilms Tumor | Stage III Kidney Wilms Tumor | Stage IV Kidney Wilms Tumor
-
National Cancer Institute (NCI)CompletedMedulloblastoma | Pineoblastoma | Supratentorial Embryonal Tumor, Not Otherwise SpecifiedUnited States