Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

NCT03372642 | Completed

• 1 other identifier: EndSP
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flatfoot; Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• AOFAS

  1 day

• SEFAS

  1 day

• SF-12

  1 day

• Meary's angle

  1 day

• Calcaneal pitch angle

  1 day

Study Arms (1)

Subtalar endorthesis

Patients who underwent subtalar endorthesis for flexible pediatric flatfoot

Device: Subtalar endorthesis

Interventions

Subtalar endorthesis DEVICE

Subtalar arthroereisis with endorthesis for pediatric flexible flat foot

Subtalar endorthesis

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

MeSH Terms

Conditions

Flatfoot; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: March 1, 2016
• Primary Completion: January 16, 2017
• Study Completion: February 20, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12