Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
27 de julio de 2026 actualizado por: Regionshospital Nordjylland
Does Correction of Pronated Foot Posture Alter Patellofemoral Alignment? A Weight-Bearing Cone Beam CT Proof-of-Concept Study in Individuals With Flexible Flatfoot
This study will look at whether correcting a flat foot position with foot orthoses, also called shoe inserts, can change the position of the kneecap during standing.
Some people with flexible flatfoot have a foot position that may affect how the lower leg and knee are aligned. This may influence the way the kneecap sits or tilts in relation to the thigh bone. Foot orthoses are often used for knee and foot problems, but it is not clear whether they directly change kneecap position when a person is standing and bearing weight.
The study will include adults with flexible flatfoot. Each participant will have low-dose, three-dimensional weight-bearing cone beam CT scans while standing in different foot positions: their natural foot position, with foot orthoses, and with foot orthoses inside a neutral running shoe. Scans will be performed with the knees straight and slightly bent.
The main hypothesis is that correcting a pronated flat foot position with foot orthoses will reduce sideways tilt and outward shift of the kneecap compared with the participant's natural foot position. The study will also examine whether changes in foot position are accompanied by changes in lower-limb rotation.
This study does not test whether foot orthoses reduce pain. Instead, it is designed to understand the immediate mechanical effect of foot correction on kneecap position.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mads K Hilligsøe, Doctor
- Número de teléfono: +4542210433
- Correo electrónico: m.hilligsoee@rn.dk
Ubicaciones de estudio
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Frederikshavn, Dinamarca, 9900
- Sportsmedicinsk Center, Frederikshavn Sygehus
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Contacto:
- Mads K Hilligsøe, Doctor
- Número de teléfono: +4542210433
- Correo electrónico: m.hilligsoee@rn.dk
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion criteria
- Age 18-35 years
Pronated foot posture, defined as a Foot Posture Index (FPI) score of ≥ +6, including a calcaneal frontal plane position sub-score of +2. 25,26
○ A trained examiner will assess FPI; inclusion is based on the right foot.
- Flexible flatfoot deformity, defined as restoration of the medial longitudinal arch during lift of the first toe.
Exclusion criteria
- Knee pain during standing or at 20° knee flexion
- Clinical signs of tibiofemoral instability
- Previous knee or foot surgery
- History of patellar dislocation
- Neuromuscular disease
- Pregnancy
- Inability to perform full weight bearing during scans
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Foot Posture Conditions
Participants will undergo standardized weight-bearing cone beam CT scans under three foot posture conditions: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a standardized neutral running shoe. Each condition will be assessed with the knees fully extended and at 20 degrees of knee flexion. The foot orthosis will be selected for each participant to correct the rearfoot toward neutral alignment. If needed, an additional forefoot wedge may be used to achieve neutral alignment. The same orthotic correction will be maintained across the relevant scan conditions. |
Standardized prefabricated foot orthoses will be used to correct a pronated foot posture toward neutral rearfoot alignment during weight-bearing. Three orthosis configurations will be available, differing in medial arch height and degree of lateral calcaneal tilt. For each participant, the orthosis that best achieves neutral rearfoot alignment will be selected. If forefoot varus prevents neutral rearfoot alignment, an additional medial forefoot wedge may be applied under the first metatarsal. The selected orthotic configuration, including any forefoot wedge, will be kept unchanged during the relevant scan conditions. The intervention will be tested both barefoot and inside a standardized neutral running shoe. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Lateral Patellar Tilt
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Lateral patellar tilt will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the sideways tilt of the kneecap in relation to the thigh bone.
It is defined as the angle between the transverse axis of the patella and the posterior condylar axis of the femur.
Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe.
Measurements will be assessed at both 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Bisect Offset
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Bisect offset will be measured as a percentage on standardized weight-bearing cone beam CT images.
The measure describes the sideways position of the kneecap in relation to the groove of the thigh bone.
It is defined as the percentage of lateral displacement of the midpoint of the patella from the midpoint of the trochlear groove.
Higher percentages indicate greater lateral displacement of the kneecap.
Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe.
Measurements will be assessed at both 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Tibial Tuberosity-Trochlear Groove Distance
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Tibial tuberosity-trochlear groove distance will be measured on standardized weight-bearing cone beam CT images and reported in millimeters.
The measure describes the side-to-side distance between the tibial tuberosity, where the patellar tendon attaches on the shin bone, and the center of the trochlear groove of the thigh bone, where the kneecap moves.
Measurements will be performed for each foot posture condition: natural foot posture, barefoot correction with foot orthoses, and correction with foot orthoses inside a neutral running shoe.
Measurements will be assessed at both 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Transmalleolar Rotation Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Transmalleolar rotation will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the rotation of the ankle axis in relation to the long axis of the foot.
The ankle axis is defined as a line through the medial and lateral malleoli.
The foot axis is defined by an adjusted sagittal foot reference plane derived from calcaneal and metatarsal head landmarks on cone beam CT.
Transmalleolar rotation is calculated as the angle between the malleolar line and this foot axis.
Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Tibial Rotation Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Tibial rotation will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the rotation of the shin bone in relation to the long axis of the foot.
It is defined as the angle between a line tangent to the posterior surface of the proximal tibia and the foot axial rotation reference.
The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT.
Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Femoral Rotation Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Femoral rotation will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the rotation of the thigh bone in relation to the long axis of the foot.
It is defined as the angle between a line tangent to the posterior femoral condyles and the foot axial rotation reference.
The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT.
Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Patellar Rotation Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Patellar rotation will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the rotation of the kneecap in relation to the long axis of the foot.
It is defined as the angle between the transverse axis of the patella and the foot axial rotation reference.
The foot axial rotation reference is an adjusted sagittal foot plane derived from calcaneal and metatarsal head landmarks on cone beam CT.
Positive values indicate external rotation relative to the foot axis, and negative values indicate internal rotation.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Navicular Plantar Position Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Navicular plantar position will be measured in millimeters on standardized weight-bearing cone beam CT images.
The measure describes the vertical position of the navicular bone, which is a bone on the inner side of the midfoot and an indicator of medial arch position.
It is defined as the perpendicular distance between the lowest point of the navicular bone and the tripod-adjusted axial foot plane.
This reference plane is based on the plantar support points of the foot.
Greater values indicate that the navicular bone is positioned farther from the plantar reference plane.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Change in Navicular Medial Displacement Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion.
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Navicular medial displacement will be measured in millimeters on standardized weight-bearing cone beam CT images.
The measure describes the side-to-side position of the navicular bone, which is a bone on the inner side of the midfoot and an indicator of foot pronation and medial arch position.
It is defined as the perpendicular distance from the most medial point of the navicular bone to the adjusted sagittal foot reference plane.
This reference plane is derived from calcaneal and metatarsal head landmarks on cone beam CT and approximates the long axis of the foot.
Greater values indicate that the navicular bone is positioned farther medially relative to the foot reference plane.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion.
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Change in Foot Axial Rotation Across Foot Posture Conditions
Periodo de tiempo: During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Foot axial rotation will be measured in degrees on standardized weight-bearing cone beam CT images.
The measure describes the toe-in or toe-out orientation of the foot.
It is defined as the angle between the adjusted sagittal foot reference plane and the global sagittal plane.
The adjusted sagittal foot reference plane is derived from calcaneal and metatarsal head landmarks and approximates the long axis of the foot.
Positive values indicate external rotation, or toe-out, and negative values indicate internal rotation, or toe-in.
Measurements will be performed for each foot posture condition at 0 and 20 degrees of knee flexion.
Change will be reported as the within-participant difference between foot posture conditions.
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During one imaging visit: natural foot posture, immediately after barefoot orthotic correction, and immediately after orthotic correction in a neutral running shoe, at 0 and 20 degrees of knee flexion
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Baseline Femoral Anteversion
Periodo de tiempo: Baseline, during the first weight-bearing cone beam CT scan
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Femoral anteversion will be measured in degrees on the baseline weight-bearing cone beam CT scan.
The measure describes the forward rotation of the femoral neck in relation to the distal femur.
It is defined as the angle between the femoral neck axis and the posterior condylar axis of the distal femur.
The femoral neck axis is defined as a line connecting the center of the femoral head and the center of the femoral neck.
The posterior condylar axis is defined as a line tangential to the most posterior aspects of the medial and lateral femoral condyles.
Positive values indicate increased femoral anteversion.
This measure will be used to describe baseline femoral morphology and to account for anatomical variation that may influence lower-limb rotational alignment.
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Baseline, during the first weight-bearing cone beam CT scan
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Baseline Foot Posture Index
Periodo de tiempo: Baseline, during the screening assessment before the imaging visit
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Foot Posture Index will be assessed at baseline by a trained examiner during standing.
The measure describes the participant's static foot posture, including the degree of pronation or supination.
The Foot Posture Index is a clinical scoring tool with six items, each scored from -2 to +2, giving a total score from -12 to +12.
Lower scores indicate a more supinated foot posture, and higher scores indicate a more pronated foot posture.
In this study, baseline pronated foot posture is defined as a Foot Posture Index score of +6 or higher, including a calcaneal frontal-plane position sub-score of +2.
Inclusion is based on the right foot.
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Baseline, during the screening assessment before the imaging visit
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Baseline Calcaneal Frontal-Plane Angle
Periodo de tiempo: Baseline, during standing assessment before foot posture correction
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Calcaneal frontal-plane angle will be measured in degrees at baseline during standing.
The measure describes the frontal-plane position of the heel bone in relation to the lower leg and reflects the degree of rearfoot valgus or varus.
It is defined as the angle between a posterior calcaneal bisection line and a vertical tibial reference line.
The posterior calcaneal bisection line is established using markers on the proximal and distal thirds of the posterior calcaneus.
The tibial reference line is defined by the vertical midline of the distal third of the tibia.
If used in the dataset coding, positive values will indicate calcaneal valgus and negative values will indicate calcaneal varus.
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Baseline, during standing assessment before foot posture correction
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Age
Periodo de tiempo: At inclusion
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At inclusion
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BMI
Periodo de tiempo: At inclusion
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At inclusion
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Sex
Periodo de tiempo: At inclusion
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At inclusion
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Perceived Comfort of the Selected Foot Orthosis Assessed by a 10-Point Numeric Rating Scale
Periodo de tiempo: Immediately after completion of the imaging protocol during the imaging visit
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Perceived comfort of the selected foot orthosis will be assessed immediately after completion of the imaging protocol using a 10-point numeric rating scale.
Participants will be asked to rate how comfortable the selected foot orthosis felt during the scan conditions.
The scale ranges from 1 to 10, where 1 indicates "not comfortable at all" and 10 indicates "maximally comfortable."
Higher scores indicate greater perceived comfort of the orthosis.
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Immediately after completion of the imaging protocol during the imaging visit
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Baseline Patellar Height Assessed by Patellar Articular Overlap
Periodo de tiempo: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Patellar height will be assessed at baseline using patellar articular overlap on weight-bearing cone beam CT images.
Patellar articular overlap describes the proportion of the kneecap joint surface that overlaps with, or is positioned within, the trochlear groove of the thigh bone.
It will be expressed as a percentage.
Higher percentages indicate greater overlap between the patellar articular surface and the trochlear groove, while lower percentages indicate less overlap.
This measure will be used to describe baseline patellofemoral morphology and alignment.
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Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Baseline Lateral Trochlear Inclination
Periodo de tiempo: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Lateral trochlear inclination will be measured in degrees on the baseline weight-bearing cone beam CT scan.
The measure describes the slope of the outer part of the trochlear groove, which is the groove of the thigh bone where the kneecap moves.
It is defined as the angle of the lateral trochlear facet in relation to the posterior condylar line of the femur.
This measure will be used to describe baseline trochlear morphology and patellofemoral anatomy.
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Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Baseline Sulcus Angle
Periodo de tiempo: Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Sulcus angle will be measured in degrees on the baseline weight-bearing cone beam CT scan.
The measure describes the shape and depth of the trochlear groove, which is the groove of the thigh bone where the kneecap moves.
It is defined as the angle formed by three points: the highest point of the medial trochlear facet, the deepest point of the trochlear groove, and the highest point of the lateral trochlear facet.
A larger sulcus angle generally indicates a flatter or shallower trochlear groove, while a smaller angle indicates a deeper groove.
This measure will be used to describe baseline trochlear morphology and patellofemoral anatomy.
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Baseline, during the first weight-bearing cone beam CT scan before foot posture correction
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Pies
- Enfermedades musculoesqueléticas
- Anomalías musculoesqueléticas
- Anomalías congénitas
- Deformidades Congénitas De Las Extremidades Inferiores
- Deformidades de las extremidades, congénitas
- Deformidades del pie
- Deformidades del pie, adquiridas
- Deformidades Congénitas Del Pie
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Pie plano
- Equipo ortopédico
- Equipo quirúrgico
- Equipos y suministros
- Dispositivos ortopulados
- Ortesis de pie
Otros números de identificación del estudio
- N-20260014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared publicly.
The study includes a small sample and weight-bearing cone beam CT imaging data, which may carry a risk of participant re-identification even after pseudonymization.
Study data will be stored on secure, access-controlled servers in accordance with GDPR and regional data protection requirements.
Results will be reported only in aggregate form.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .