- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04269421
Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age (CSSPORT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Elena Maredi, MD
- Phone Number: 0516366837
- Email: elena.maredi@gmail.com
Study Locations
-
-
-
Bologna, Italy, 40136
- IRCCS - Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Idiopathic Flatfoot;
- Surgical treatment with arthrorisis of subtalar joint;
- Follow-up> 48 months
- Completeness of the clinical-radiographic documentation.
Exclusion Criteria:
- Diagnosis of secondary flat valgus foot;
- Flat foot treated with other techniques;
- Incomplete clinical documentation;
- Patients who refuse to undergo the study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patiens Able to Return to Sport After Surgery
Time Frame: 1 year
|
timing, sport level, resilience
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plantar arch index
Time Frame: 1 year
|
The plantar arch index establishes a relationship between the central and posterior regions of the footprint, and it is calculated as follows:A line is drawn tangent to the medial forefoot edge and at the heel region. The mean point of this line is calculated. From this mean point, a perpendicular line is drawn crossing the footprint. The same procedure is repeated at the heel tangency. Measurements are obtained of the width of the central region of the footprint (A) and of the heel region (B) in millimeters. The plantar arch index is calculated by dividing the A value by B (PAI = A/B). |
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSSPORT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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