NCT04269421

Brief Summary

The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age, the aim is to restore and maintain the physiological alignment between the talus and the calcaneus during bone maturation. There are few articles in the literature that talk about the return to sport of pediatric patients after surgery. The aim of the study is to review patients operated on remotely kick heel and describe how they return in their sports (resilience, type of activities carried out, recovery times). The aim of this study is to evaluate the clinical and functional results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe the method of resuming sports activities, analyzing the timing and difficulties declared by patients after surgery, with the help of specific questionnaires.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

February 10, 2020

Last Update Submit

June 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Patiens Able to Return to Sport After Surgery

    timing, sport level, resilience

    1 year

Secondary Outcomes (1)

  • plantar arch index

    1 year

Interventions

arthrosis of the subtalar joint with a screw in the talus bone to stop pathological pronation of the heel

Also known as: arthrosis of the subtalar joint

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The analysis will be performed on pediatric patients undergoing surgical treatment for correction of idiopathic flatfoot in the Orthopedics Pediatric department of the IRCCS Rizzoli Orthopedic Institute in the years 2016-2017.

You may qualify if:

  • Idiopathic Flatfoot;
  • Surgical treatment with arthrorisis of subtalar joint;
  • Follow-up\> 48 months
  • Completeness of the clinical-radiographic documentation.

You may not qualify if:

  • Diagnosis of secondary flat valgus foot;
  • Flat foot treated with other techniques;
  • Incomplete clinical documentation;
  • Patients who refuse to undergo the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS - Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 13, 2020

Study Start

March 1, 2020

Primary Completion

November 30, 2020

Study Completion

June 6, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations