About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Flexible flatfoot deformity, defined as restoration of the medial longitudinal arch during lift of the first toe.
Disqualifiers
Knee pain during standing or at 20° knee flexion
Clinical signs of tibiofemoral instability
Previous knee or foot surgery
History of patellar dislocation
Trial design
Single group
Treatments tested in this trial
Foot Orthoses
DeviceStandardized 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Lateral Patellar Tilt
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.
Change in Bisect Offset
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.
Secondary outcomes
Change in Tibial Tuberosity-Trochlear Groove Distance
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.
Change in Transmalleolar Rotation Across Foot Posture Conditions
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.
Change in Tibial Rotation Across Foot Posture Conditions
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.
Change in Femoral Rotation Across Foot Posture Conditions
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.
Other outcomes
Change in Navicular Plantar Position Across Foot Posture Conditions
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.
Change in Navicular Medial Displacement Across Foot Posture Conditions
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.
Change in Foot Axial Rotation Across Foot Posture Conditions
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.
Baseline Femoral Anteversion
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.
Sponsors and contacts
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Regionshospital Nordjylland
Lead sponsor
Bispebjerg Hospital
Collaborator
Frederiksberg University Hospital
Collaborator
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