Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Completed

• Conditions: Pediatric ALL; Flatfoot
• Interventions: Device: Subtalar endorthesis

• Registration Number: NCT03372642
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-01-16
• Study Completion: 2017-02-20
• Status Verified: 2017-12
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-13
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subtalar endorthesis	Subtalar endorthesis	Patients who underwent subtalar endorthesis for flexible pediatric flatfoot

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
SEFAS	1 day	Self-reported foot and ankle score (SEFAS)
SF-12	1 day	12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)
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
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
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
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