Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2024-05-31
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Control Group
Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).
Histological Analysis
For the study, a minimal part of the periarticular tissue, specifically the sinus tarsi juxta-articular fatty tissue, that is normally dissected and discarded during the surgical operation of insertion and removal of the calcaneo-stop screw, will be analyzed
Study Group
Study group are patient that remove the calcaneo-stop screw (age from 14 years old)
Histological Analysis
For the study, a minimal part of the periarticular tissue, specifically the sinus tarsi juxta-articular fatty tissue, that is normally dissected and discarded during the surgical operation of insertion and removal of the calcaneo-stop screw, will be analyzed
Interventions
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Histological Analysis
For the study, a minimal part of the periarticular tissue, specifically the sinus tarsi juxta-articular fatty tissue, that is normally dissected and discarded during the surgical operation of insertion and removal of the calcaneo-stop screw, will be analyzed
Eligibility Criteria
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Inclusion Criteria
* Patients aged 14 years old and above that will remove the calcaneo stop screw, in place for at least 3 years after the implant, will be recruited
* Patients willing and able to give informed consent for the participation in the study. For underage patients, a parent/legal representative will give consent for the participation in the study.
* Male and female patients in fertile age can be recruited.
Control Group:
* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Exclusion Criteria
* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
Study Group:
* Patients suffering from post-operative complications
* Syndromic patients
* Previous foot malformation (synostosis, congenital clubfoot)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
10 Years
ALL
Yes
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Professor Giacomo Placella
Professor
Locations
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Ircss Ospedale San Raffaele
Milan, Lombardy, Italy
Università Vita-Salute San Raffaele
Milan, , Italy
Countries
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Facility Contacts
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Francesco Pezone
Role: primary
Role: backup
References
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De Pellegrin M, Moharamzadeh D. Subtalar Arthroereisis for Surgical Treatment of Flexible Flatfoot. Foot Ankle Clin. 2021 Dec;26(4):765-805. doi: 10.1016/j.fcl.2021.07.007. Epub 2021 Oct 4.
Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.
Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop. 2010 Apr;4(2):107-21. doi: 10.1007/s11832-010-0239-9. Epub 2010 Feb 18.
Harris EJ. The natural history and pathophysiology of flexible flatfoot. Clin Podiatr Med Surg. 2010 Jan;27(1):1-23. doi: 10.1016/j.cpm.2009.09.002.
Jane MacKenzie A, Rome K, Evans AM. The efficacy of nonsurgical interventions for pediatric flexible flat foot: a critical review. J Pediatr Orthop. 2012 Dec;32(8):830-4. doi: 10.1097/BPO.0b013e3182648c95.
De Pellegrin M, Moharamzadeh D, Strobl WM, Biedermann R, Tschauner C, Wirth T. Subtalar extra-articular screw arthroereisis (SESA) for the treatment of flexible flatfoot in children. J Child Orthop. 2014 Dec;8(6):479-87. doi: 10.1007/s11832-014-0619-7. Epub 2014 Nov 21.
Rein S, Manthey S, Zwipp H, Witt A. Distribution of sensory nerve endings around the human sinus tarsi: a cadaver study. J Anat. 2014 Apr;224(4):499-508. doi: 10.1111/joa.12157. Epub 2014 Jan 29.
Freeman MA, Wyke B. The innervation of the knee joint. An anatomical and histological study in the cat. J Anat. 1967 Jun;101(Pt 3):505-32. No abstract available.
Hagert E, Forsgren S, Ljung BO. Differences in the presence of mechanoreceptors and nerve structures between wrist ligaments may imply differential roles in wrist stabilization. J Orthop Res. 2005 Jul;23(4):757-63. doi: 10.1016/j.orthres.2005.01.011. Epub 2005 Mar 29.
Hagert E. Proprioception of the wrist joint: a review of current concepts and possible implications on the rehabilitation of the wrist. J Hand Ther. 2010 Jan-Mar;23(1):2-17. doi: 10.1016/j.jht.2009.09.008. Epub 2009 Dec 5.
Other Identifiers
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HTSW1
Identifier Type: -
Identifier Source: org_study_id
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