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

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ClinicalTrials.gov Identifier: NCT04894942
Recruitment Status : Not yet recruiting
First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
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.

Condition or disease Intervention/treatment
Calcaneonavicular Coalition Other: American Orthopaedic Foot and Ankle Society Score (AOFASS)

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Study Type : Observational
Estimated Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health


Intervention Details:
  • Other: American Orthopaedic Foot and Ankle Society Score (AOFASS)
    calculation of the score AOFASS before and after the surgery


Primary Outcome Measures :
  1. Comparison of scores before surgery and after surgery at 1 month, for all the operated patients [ Time Frame: 1 month ]

    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.


  2. Comparison of scores before surgery and after surgery at 3 months for all the operated patients [ Time Frame: 3 months ]

    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. Comparison of scores before surgery and after surgery at 1 12 months for all the operated patients [ Time Frame: 12 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894942


Contacts
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Contact: Quentin Ballouhey, MD 0555049027 quentin.ballouhey@unilim.fr
Contact: Quentin Ballouhey, MD quentin.ballouhey@unilim.fr

Locations
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France
Pediatric emergency department
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT04894942    
Other Study ID Numbers: Ballouhey _anterior process
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No