- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03460418
Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone.
Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.
This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Brussels, Bélgica, 1020
- CHU Brugmann
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.
Exclusion Criteria:
None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Multiloc nail
Fracture treated with a Multiloc nail (patients treated between 2012 and 2017)
|
Assessment of the different outcomes by means of a phone contact
|
Philos plate
Fracture treated with a Philos plate (patients treated between 2012 and 2017)
|
Assessment of the different outcomes by means of a phone contact
|
arthroplasty
Fracture treated by arthroplasty (patients treated between 2012 and 2017)
|
Assessment of the different outcomes by means of a phone contact
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fracture classification (AO)
Periodo de tiempo: one year
|
Fracture classification according to the "Müller AO Classification of fractures - long bones"
|
one year
|
Fracture classification (NEER)
Periodo de tiempo: one year
|
Fracture classification according to the "Neer classification of proximal humeral fractures"
|
one year
|
Dash score
Periodo de tiempo: one year
|
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.
The score is computed according to this formula: ([(sum of n responses)/n] -1)(25) where n represents the number of completed items.
A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.The score ranges from 0 (no disability) to 100 (most severe disability).
|
one year
|
Constant score
Periodo de tiempo: one year
|
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters.
These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.
The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.
The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
The higher the score, the higher the quality of the function.
|
one year
|
QoL 36
Periodo de tiempo: one year
|
The QoL 36 quality of life questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
|
one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Victorien Gauchez, CHU Brugmann
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHUB-Multiloc
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Fracturas humerales
-
University Hospital, BrestTerminadoArtroscopia Artrodesis Gleno-humeralFrancia
-
University Hospital, Clermont-FerrandReclutamientoFractura de diáfisis humeral | Fractura de la extremidad superior humeralFrancia
-
Centre Hospitalier Universitaire DijonReclutamientoFractura del eje humeralFrancia
-
Hopital de l'Enfant-JesusTerminadoFractura de diáfisis humeralCanadá
-
McGill University Health Centre/Research Institute...Canadian Orthopaedic Trauma SocietyDesconocidoFractura diafisaria humeralCanadá
-
Hacettepe UniversityDesconocido
-
University of HelsinkiFinnish Institute for Health and WelfareDesconocido
-
University Hospital, LinkoepingTerminadoFractura humeralSuecia
-
University of HelsinkiHelsinki University Central Hospital; Finnish Institute for Health and WelfareActivo, no reclutando
-
KK Women's and Children's HospitalTerminadoFractura humeral supracondílea pediátricaSingapur
Ensayos clínicos sobre Phone contact
-
Central Hospital, Nancy, FranceTerminadoSuicidio y autoagresiónFrancia
-
Abbott Medical DevicesTerminadoFlutter auricular típicoEstados Unidos, Canadá
-
DePuy InternationalTerminadoArtroplastia, Reemplazo, RodillaIrlanda
-
L.V.A. BoersmaTerminado