Subtalar Extra-articular Screw Arthroereisis

Subtalar Extra-articular Screw Arthroereisis: How Does the Screw Work

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Flatfoot, Flexible
• Intervention / Treatment: Other: Histological Analysis

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Università Vita-Salute San Raffaele
    • Contact: Francesco Pezone
    • Contact: Email: f.pezone@studenti.unisr.it
  • Lombardy
    • Milan, Lombardy, Italy, 20149
      • IRCSS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

Study Group:

• 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:

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).	Other: 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)	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint (%)	Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue	Time 0 (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	Number and type of nervous fibers	Time 0 (baseline)

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: HTSW1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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