Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children

Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study

Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.

Study Overview

• Status: Not yet recruiting
• Conditions: Calcaneonavicular Coalition
• Intervention / Treatment: Other: American Orthopaedic Foot and Ankle Society Score (AOFASS)

• Study Type: Observational
• Enrollment (Anticipated): 11

Contacts and Locations

• Study Contact: Name: Quentin Ballouhey, MD; Phone Number: 0555049027; Email: quentin.ballouhey@unilim.fr
• Study Contact Backup: Name: Quentin Ballouhey, MD; Email: quentin.ballouhey@unilim.fr

Study Locations

• France
  • Limoges, France, 87000
    • Pediatric Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Child <16 years with calcaneonavicular coalition with Magnetic resonance imaging diagnosis and already treated orthopedically in the initial treatment of the coalition

Description

Inclusion Criteria:

• Child <16 years
• Child with calcaneonavicular coalition
• Magnetic resonance imaging diagnosis
• Patient already treated orthopedically in the initial treatment of the coalition

Exclusion Criteria:

• Child >=16 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of scores before surgery and after surgery at 1 month, for all the operated patients	Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.	1 month
Comparison of scores before surgery and after surgery at 3 months for all the operated patients	Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.	3 months
Comparison of scores before surgery and after surgery at 1 12 months for all the operated patients	Calculation of the American Orthopaedic Foot and Ankle Society Score. This is an instrument for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The maximal score is 100 points, indicating no symptoms or impairments.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Ballouhey _anterior process

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No