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Completed

NCT Number: NCT03372642

Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical impairment, pain, and difficulty walking. We evaluate the radiographic effectiveness of intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with final follow-up at skeletal maturity.

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Key information

Conditions

Flatfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Limb Deformities, Congenital Lower Extremity Deformities, Congenital Lymphatic Diseases Lymphoproliferative Disorders Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Talipes

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females
  • age ≥ 14 years at the time of the visit
  • patients who underwent subtalar endothesis for the treatment of the pediatric flexible flatfoot from January 2011 to March 2015.

Exclusion criteria

  • age <14 years at the time of the visit
  • patients with comorbidities that make it difficult to return to the hospital for consultation or who have removed the device for discomfort
  • female patients who do not exclude (by self-declaration, as clinical practice) a state of pregnancy

Treatment and study plan

Subtalar endorthesis

Device

Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

Primary outcomes

  1. lateral talocalcaneal angle

    Time frame: 1 day

    lateral talocalcaneal angle (LTC) on the lateral view of the radiographs: it is traced between the long axis of the talus and the plantar surface of the calcaneus

Secondary outcomes

  1. AOFAS

    Time frame: 1 day

    American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale. It is a measure of ankle and hidfoot function. It comprises nine questions and covers three categories: pain (40 points), function (50 points) and alignment (10 points). These are all summed together for a maximun score of 100 points (best otucome) and a minimum score of 0 (worst outcome). It includes a mixture of questions that are both subjective and objective in nature.

  2. SEFAS

    Time frame: 1 day

    Self-reported foot and ankle score (SEFAS)

  3. SF-12

    Time frame: 1 day

    12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)

  4. Meary's angle

    Time frame: 1 day

    Meary's angle (MA) on the lateral view of the radiographs, also known as talar-first metatarsal angle: it is formed by a line through the long axis of the talus and the axis of the first metatarsal (the negative values indicate a plantar apex of the angle as it happens in the flatfeet

  5. Calcaneal pitch angle

    Time frame: 1 day

    Calcaneal pitch angle on the lateral view of the radiographs: it is subtended by the intersection of a line parallel to the floor with a line connecting the two most inferior points on the calcaneus

  6. Anteroposterior talonavicular coverage angle

    Time frame: 1 day

    Anteroposterior talonavicular coverage angle (APTN) on the anteroposterior view of the radiographs: it is the angle between the lines connecting the endpoints of the talar and navicular articular surfaces

  7. Talonavicular uncoverage percent

    Time frame: 1 day

    Talonavicular uncoverage percent (TNU) on the anteroposterior view of the radiographs: it is a ratio between the angle subtended by the line connecting the endpoints of the talar articular surface and a line drawn from the midpoint of the previous line and the medial endpoint of the navicular articular surface. It indicates the percentage of the talar head not covered by the navicular

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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