Patellofemoral JointNCT07678840
Effect of Foot Orthoses on Kneecap Position in Adults With Flexible Flatfoot
A study testing Foot Orthoses in people with Patellofemoral Joint and Flatfoot, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Joint, Flatfoot
- What is being tested?
- Foot Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Sportsmedicinsk Center, Frederikshavn Sygehus
Frederikshavn, 9900
Mads K Hilligsøe, Doctor, +4542210433, m.hilligsoee@rn.dk
About this study
Official title: 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.
Read more
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.
- Conditions
- Patellofemoral Joint, Flatfoot
- Being tested
- Foot Orthoses
- Keywords
- Flatfoot, Foot pronation, Foot orthoses, Patellofemoral alignment, Patellar tilt, Kneecap position, Lower-limb alignment, Lower-limb rotation, Weight-bearing Imaging, Cone-Beam Computed Tomography
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot OrthosesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Foot Posture Conditions | Experimental | 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. Receives: Device: Foot Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Change in Patellar Rotation Across Foot Posture Conditions
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- Bispebjerg Hospital, Frederiksberg University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678840
- Sponsor's protocol ID
- N-20260014
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Correction of Pronated Foot Posture Alter Patellofemoral Alignment? A Weight-Bearing Cone Beam CT Proof-of-Concept Study in Individuals With Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT07678840
- Acronym / sponsor ID
- N-20260014
- Conditions
- Patellofemoral Joint, Flatfoot
- Keywords
- Flatfoot, Foot pronation, Foot orthoses, Patellofemoral alignment, Patellar tilt, Kneecap position, Lower-limb alignment, Lower-limb rotation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- Bispebjerg Hospital, Frederiksberg University Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot Posture Conditions | Experimental | Device: Foot OrthosesParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot OrthosesStandardized 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. | Device | Foot Posture Conditions |
Primary outcome
Change in Lateral Patellar Tilt
Time frame: 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
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
Time frame: 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
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.
5 secondary outcomes
Change in Tibial Tuberosity-Trochlear Groove Distance
Time frame: 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
Change in Transmalleolar Rotation Across Foot Posture Conditions
Time frame: 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
Change in Tibial Rotation Across Foot Posture Conditions
Time frame: 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
Change in Femoral Rotation Across Foot Posture Conditions
Time frame: 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
Change in Patellar Rotation Across Foot Posture Conditions
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Orthoses in people with Patellofemoral Joint and Flatfoot, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mads K Hilligsøe, Doctor (+4542210433, m.hilligsoee@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lateral Patellar Tilt (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.