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Evaluation of the Anterior Tibialis Tendon Using Elastography in Patients With Hallux Valgus

Evaluation of the Anterior Tibialis Tendon Using Elastography in Patients With Hallux Valgus

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07327112
Acronym
hallux valgus
Enrollment
90
Registered
2026-01-08
Start date
2026-01-01
Completion date
2026-03-31
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elastography, Hallux Valgus Deformity

Brief 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). 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.

Interventions

None listed

Sponsors

Kastamonu University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
Tibialis anterior tendon elasticity value1 Day
Determining the distal location of the anterior tibial tendon using ultrasound1 days

Contacts

Primary ContactRecep Taşkin, Ass. Prof.
rtaskin@kastamonu.edu.tr+905453704817

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026