Hallux Valgus Deformityhallux valgusNCT07327112
Evaluation of the Anterior Tibialis Tendon Using Elastography in Patients With Hallux Valgus
An observational study of Hallux Valgus Deformity and Elastography, run by Kastamonu University.
Trial summary
To elucidate the relationship between changes in the mechanical properties of the tibialis anterior tendon and deformity in patients with hallux valgus, a case-control study is planned to quantitatively measure tendon stiffness using shear-wave elastography (SWE). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus Deformity, Elastography
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Mar 2026
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who visited the orthopedics outpatient clinic at Kastamonu Education and Research Hospital during the study period and were requested to undergo tibialis anterior tendon elastography examination
Who may be able to join
- Aged 18 years or older and able to provide written informed consent
- Compliance with procedures and ability to maintain standard position during measurement
- HV group: Weight-bearing radiograph showing HVA ≥15° (with IMA increase) - Control: no deformity, HVA <15°
- Selection of a single index foot in the same individual (highest HVA/symptomatic in HV; dominant in control)
- Availability or ability to obtain current radiographic measurements within the last 3 months
Who cannot join
- Previous foot/ankle surgery on the same lower extremity or significant trauma/fracture within the last 12 months
- Rheumatological/metabolic diseases (RA, spondyloarthritis, gout), neuropathy/peripheral vascular disease
- Drug/procedure affecting tendons: systemic or local corticosteroids within the last 6 months; fluoroquinolone use within the last 3 months
- Other significant foot deformity (advanced pes planus/cavus, hallux rigidus/varus) or professional intensive training (exclude or subgroup at your discretion)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To elucidate the relationship between changes in the mechanical properties of the tibialis anterior tendon and deformity in patients with hallux valgus, a case-control study is planned to quantitatively measure tendon stiffness using shear-wave elastography (SWE). Two groups will be compared: adults with radiographically confirmed hallux valgus (HVA (Hallux valgus angle) ≥15°) and age- and gender-matched healthy controls. The primary outcome is the elasticity modulus of the tibialis anterior tendon measured by SWE (kPa). Measurements will be performed using a high-frequency linear probe, with the probe positioned parallel to the tendon fibers and the foot in the standard ankle position, with three repetitions performed on each subject; the mean of stable frames will be used in the analysis. Secondary variables will be the relationships between tendon thickness/cross-sectional area, clinical angle parameters (HVA, IMA (intermetatarsal angle)), and functional scores. In the reliability sub-study, intra- and inter-observer ICC (Intraclass Correlation Coefficient), SEM (Standard Error of Measurement), and MDC (Minimal Detectable Change) will be calculated.
The sample size was calculated for a two-sample, two-tailed t-test with α=0.05 and 80% power assumptions, targeting a clinically meaningful medium-to-high effect size (Cohen d=0.60); at least 45 patients (45 with hallux valgus + 45 healthy) were planned. Parametric/non-parametric tests appropriate for the distribution and ANCOVA for potential confounders (age, gender, BMI, foot dominance) will be used in the analyses. The study is expected to objectively demonstrate whether tibialis anterior tendon stiffness changes in hallux valgus, thereby clarifying the muscle-tendon contributions to pathomechanics and laying the groundwork for targeted strategies in both conservative and surgical treatment planning.
- Conditions
- Hallux Valgus Deformity, Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hallux Valgus | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibialis anterior tendon elasticity value
Measured: 1 Day
Determining the distal location of the anterior tibial tendon using ultrasound
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus DeformityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Taşkin, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327112
- Sponsor's protocol ID
- KastamonuU123
- Acronym
- hallux valgus
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anterior Tibialis Tendon Using Elastography in Patients With Hallux Valgus
- ClinicalTrials.gov ID
- NCT07327112
- Acronym / sponsor ID
- hallux valgus / KastamonuU123
- Conditions
- Hallux Valgus Deformity, Elastography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Jan 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.
To elucidate the relationship between changes in the mechanical properties of the tibialis anterior tendon and deformity in patients with hallux valgus, a case-control study is planned to quantitatively measure tendon stiffness using shear-wave elastography (SWE). Two groups will be compared: adults with radiographically confirmed hallux valgus (HVA (Hallux valgus angle) ≥15°) and age- and gender-matched healthy controls. The primary outcome is the elasticity modulus of the tibialis anterior tendon measured by SWE (kPa). Measurements will be performed using a high-frequency linear probe, with the probe positioned parallel to the tendon fibers and the foot in the standard ankle position, with three repetitions performed on each subject; the mean of stable frames will be used in the analysis. Secondary variables will be the relationships between tendon thickness/cross-sectional area, clinical angle parameters (HVA, IMA (intermetatarsal angle)), and functional scores. In the reliability sub-study, intra- and inter-observer ICC (Intraclass Correlation Coefficient), SEM (Standard Error of Measurement), and MDC (Minimal Detectable Change) will be calculated.
The sample size was calculated for a two-sample, two-tailed t-test with α=0.05 and 80% power assumptions, targeting a clinically meaningful medium-to-high effect size (Cohen d=0.60); at least 45 patients (45 with hallux valgus + 45 healthy) were planned. Parametric/non-parametric tests appropriate for the distribution and ANCOVA for potential confounders (age, gender, BMI, foot dominance) will be used in the analyses. The study is expected to objectively demonstrate whether tibialis anterior tendon stiffness changes in hallux valgus, thereby clarifying the muscle-tendon contributions to pathomechanics and laying the groundwork for targeted strategies in both conservative and surgical treatment planning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hallux Valgus | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited the orthopedics outpatient clinic at Kastamonu Education and Research Hospital during the study period and were requested to undergo tibialis anterior tendon elastography examination
Key inclusion criteria (5 listed)
- Aged 18 years or older and able to provide written informed consent
- Compliance with procedures and ability to maintain standard position during measurement
- HV group: Weight-bearing radiograph showing HVA ≥15° (with IMA increase) - Control: no deformity, HVA <15°
- Selection of a single index foot in the same individual (highest HVA/symptomatic in HV; dominant in control)
- Availability or ability to obtain current radiographic measurements within the last 3 months
Key exclusion criteria (4 listed)
- Previous foot/ankle surgery on the same lower extremity or significant trauma/fracture within the last 12 months
- Rheumatological/metabolic diseases (RA, spondyloarthritis, gout), neuropathy/peripheral vascular disease
- Drug/procedure affecting tendons: systemic or local corticosteroids within the last 6 months; fluoroquinolone use within the last 3 months
- Other significant foot deformity (advanced pes planus/cavus, hallux rigidus/varus) or professional intensive training (exclude or subgroup at your discretion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tibialis anterior tendon elasticity value
Time frame: 1 Day
Determining the distal location of the anterior tibial tendon using ultrasound
Time frame: 1 days
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes. yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus Deformity and Elastography, run by Kastamonu University.
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 5 inclusion and 4 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Recep Taşkin, Ass. Prof. (+905453704817, rtaskin@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibialis anterior tendon elasticity value (time frame: 1 Day). 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 8 Jan 2026.