An observational study in Hallux Valgus Deformity and Elastography, sponsored by Kastamonu University. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Kastamonu University · Observational
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.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 35 observational studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Kastamonu University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
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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
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tibialis anterior tendon elasticity value
Time frame: 1 Day
Determining the distal location of the anterior tibial tendon using ultrasound
Time frame: 1 days
No study locations are listed for this record.
Plan to share: Yes — yes
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available persistantly on 1.6.2026.
Access criteria: Upon reasonable request principal investigator will share the data.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Kastamonu University