- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04904640
Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software (CTdevice)
Evaluation of the Reconstruction of Biomechanical Parameters Provided by Three Different Hip Stem Designs in Developmental Hip Dysplasia Using a 3D CT-based Software for Surgical Planning
Descripción general del estudio
Descripción detallada
Pre-operative planning in hip arthroplasty with dedicated software is a useful guide to provide a better reconstruction of the biomechanical parameters of the replaced hip and to optimize the choice of component, improving the geometric understanding of the hip anatomy and the interaction between the native morphological structure and the prosthetic component.
The use of a 3D CT-based software for pre-operative planning may provide a better knowledge of the hip anatomy, simulating the biomechanical parameters more closely than a 2D X-ray-based software. In addition, it is the only way to anticipate the correct interaction between the prosthetic components, or the combined anteversion, a key factor in preventing implant instability.
Severe hip deformities, like developmental hip dysplasia, may not be adequately reconstructed by every implant and 3D pre-operative CT may increase the three-dimensional anatomical knowledge of the hip, improving the choice of the correct implant and possibly reducing the possible consequences of intra and post-operative complications.
Therefore, the purpose of this study is to pre-operatively plan, in a random series of 200 native pelvis and thigh CT scans performed in patients with hip dysplasia, 3 different types of hip stem designs using the 3D Hip-Op software, with the aim of analyzing, on the CT simulations, the percentage of adequate reconstruction of the optimal biomechanical parameters (combined anteversion between 25°-50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80%). The percentage of every stem design providing the optimal reconstruction in dysplastic hips (all the 5 parameters matched) will be assessed. The single parameters, especially the combined anteversion, the offset restoration and the leg lengthening, will be assessed for every simulation.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bologna, Italia, 40136
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
-
-
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:
- definition of developmental hip dysplasia according to Wiberg (center edge angle <20°)
- pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus
Exclusion Criteria:
- other types of hip pathologies
- inadequate Ct scans
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
CLS stem
CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning
|
In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
|
Wagner cone stem
Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning
|
In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
|
Aptafix stem
Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning
|
In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Correct Reconstruction CLS
Periodo de tiempo: Day 0
|
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
|
Day 0
|
Correct Reconstruction Wagner Cone
Periodo de tiempo: Day 0
|
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
|
Day 0
|
Correct Reconstruction Aptafix
Periodo de tiempo: Day 0
|
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time).
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 the worst
|
Day 0
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Combined Anteversion CLS
Periodo de tiempo: Day 0
|
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Combined Anteversion Wagner Cone
Periodo de tiempo: Day 0
|
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Combined Anteversion Aptafix
Periodo de tiempo: Day 0
|
Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Offset CLS
Periodo de tiempo: Day 0
|
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Offset Wagner Cone
Periodo de tiempo: Day 0
|
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Offset Aptafix
Periodo de tiempo: Day 0
|
Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Leg Lengthening CLS
Periodo de tiempo: Day 0
|
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Leg Lengthening Wagner Cone
Periodo de tiempo: Day 0
|
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Leg Lengthening Aptafix
Periodo de tiempo: Day 0
|
Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
|
Day 0
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Francesco Traina, Professor, IRCCS Istituto Ortopedico Rizzoli
Publicaciones y enlaces útiles
Publicaciones Generales
- Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.
- Argenson JN, Ryembault E, Flecher X, Brassart N, Parratte S, Aubaniac JM. Three-dimensional anatomy of the hip in osteoarthritis after developmental dysplasia. J Bone Joint Surg Br. 2005 Sep;87(9):1192-6. doi: 10.1302/0301-620X.87B9.15928.
- Sugano N, Takao M, Sakai T, Nishii T, Miki H. Does CT-based navigation improve the long-term survival in ceramic-on-ceramic THA? Clin Orthop Relat Res. 2012 Nov;470(11):3054-9. doi: 10.1007/s11999-012-2378-4.
- Castagnini F, Valente G, Crimi G, Taddei F, Bordini B, Stea S, Toni A. Component positioning and ceramic damage in cementless ceramic-on-ceramic total hip arthroplasty. J Orthop Sci. 2019 Jul;24(4):643-651. doi: 10.1016/j.jos.2018.12.011. Epub 2019 Jan 4.
Enlaces Útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 29/2021/Oss/IOR
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 Hip stem
-
The University of Hong KongUniversity of CambridgeTerminadoProblemas educativosHong Kong
-
StemMedical A/SAún no reclutando
-
Immunis, Inc.ReclutamientoAtrofia muscularEstados Unidos
-
University of MinhoHospital de BragaTerminadoArtroplastia de Rodilla, TotalPortugal
-
Zimmer BiometReclutamiento
-
Oregon Research Behavioral Intervention Strategies...National Institute on Minority Health and Health Disparities (NIMHD)TerminadoDesarrollo del lenguajeEstados Unidos
-
Oregon Research Behavioral Intervention Strategies...Reclutamiento
-
University of Massachusetts, LowellNational Heart, Lung, and Blood Institute (NHLBI); Tufts University; National Institute... y otros colaboradoresTerminado
-
Samsung Medical CenterSamsung ElectronicsTerminado
-
Throne Biotechnologies Inc.Aún no reclutandoNeumonía del Síndrome Respiratorio Agudo Severo (SARS)