Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372642
• Other study ID #: EndSP
• Status: Completed
• Phase: N/A
• First received: December 8, 2017
• Last updated: December 13, 2017
• Start date: March 1, 2016
• Est. completion date: February 20, 2017

Study information

• Verified date: December 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flatfoot
• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lateral talocalcaneal angle	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	1 day
Secondary	AOFAS	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.	1 day
Secondary	SEFAS	Self-reported foot and ankle score (SEFAS)	1 day
Secondary	SF-12	12-Item Short Form Health Survey (SF-12) with its Mental and Physical Component Scores (MCS and PCS)	1 day
Secondary	Meary's angle	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	1 day
Secondary	Calcaneal pitch angle	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	1 day
Secondary	Anteroposterior talonavicular coverage angle	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	1 day
Secondary	Talonavicular uncoverage percent	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	1 day