Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Sponsor
Istituto Ortopedico Galeazzi (Other)
Overall Status
Completed
CT.gov ID
NCT03372642
Collaborator
(none)
60
11.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Subtalar endorthesis

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 16, 2017
Actual Study Completion Date :
Feb 20, 2017

Arms and Interventions

Arm Intervention/Treatment
Subtalar endorthesis

Patients who underwent subtalar endorthesis for flexible pediatric flatfoot

Device: Subtalar endorthesis
Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

Outcome Measures

Primary Outcome Measures

  1. lateral talocalcaneal angle [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

  1. AOFAS [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 [1 day]

    Self-reported foot and ankle score (SEFAS)

  3. SF-12 [1 day]

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

  4. Meary's angle [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Istituto Ortopedico Galeazzi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier:
NCT03372642
Other Study ID Numbers:
  • EndSP
First Posted:
Dec 13, 2017
Last Update Posted:
Dec 15, 2017
Last Verified:
Dec 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2017