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Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03372642
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi
  Purpose
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.

Condition Intervention
Flatfoot Pediatric ALL Device: Subtalar endorthesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Galeazzi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • AOFAS [ Time Frame: 1 day ]
    American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale

  • SEFAS [ Time Frame: 1 day ]
    Self-reported foot and ankle score (SEFAS

  • SF-12 [ Time Frame: 1 day ]
    12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)

  • 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

  • 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

  • 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

  • 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


Enrollment: 60
Actual Study Start Date: March 1, 2016
Study Completion Date: February 20, 2017
Primary Completion Date: January 16, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subtalar endorthesis
Patients who underwent subtalar endorthesis for flexible pediatric flatfoot
Device: Subtalar endorthesis
Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We retrospectively review 60 consecutive patients who underwent surgical treatment with subtalar arthroereisis for pediatric flexible flatfoot at the authors' institution from January 2011 to March 2015.
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03372642     History of Changes
Other Study ID Numbers: EndSP
First Submitted: December 8, 2017
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities