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Trial record 1 of 261364 for:    ALL
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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
December 8, 2017
December 13, 2017
December 13, 2017
March 1, 2016
January 16, 2017   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot
Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
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.
  • Flatfoot
  • Pediatric ALL
Device: Subtalar endorthesis
Subtalar arthroereisis with endorthesis for pediatric flexible flat foot
Subtalar endorthesis
Patients who underwent subtalar endorthesis for flexible pediatric flatfoot
Intervention: Device: Subtalar endorthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 20, 2017
January 16, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03372642
EndSP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Istituto Ortopedico Galeazzi
Istituto Ortopedico Galeazzi
Not Provided
Not Provided
Istituto Ortopedico Galeazzi
December 2017