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Clinical Trials/NCT03372642
NCT03372642
Completed
Not Applicable

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio0 sites60 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Flatfoot
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
60
Primary Endpoint
lateral talocalcaneal angle
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
February 20, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • AOFAS(1 day)
  • SEFAS(1 day)
  • SF-12(1 day)
  • Meary's angle(1 day)
  • Calcaneal pitch angle(1 day)
  • Anteroposterior talonavicular coverage angle(1 day)
  • Talonavicular uncoverage percent(1 day)

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