NCT06389253|Unknown
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Sponsor study identifier
observational
40
1 country
2
Study Start
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2025
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Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2024
Actual (reported)April 29, 2024
Actual (reported)May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Endpoint (%)
Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue
Time 0 (baseline)
Secondary Endpoint
Time 0 (baseline)
Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).
Study group are patient that remove the calcaneo-stop screw (age from 14 years old)
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
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Patients with subtalar extraarticular screw arthroereisis, gender male and female, no comorbidities. Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old). Study group are patient that remove the calcaneo-stop screw (age from 14 years old)
Ircss Ospedale San Raffaele
Milan, Lombardy, 20149, Italy
Università Vita-Salute San Raffaele
Milan, 20132, Italy
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.
First Submitted
April 24, 2024
First Posted
April 29, 2024
Study Start
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2025
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 1, 2024
Record last verified: 2024-04
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