Subtalar Extra-articular Screw Arthroereisis

NCT06389253 | Not Yet Recruiting

• 1 other identifier: HTSW1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Flatfoot, Flexible

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint (%)

  Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue

  Time 0 (baseline)

Secondary Outcomes (1)

• Secondary Endpoint

  Time 0 (baseline)

Study Arms (2)

Control Group

Control group are patients that will insert the calcaneo-stop screw (age between 10 and 14 years old).

Other: Histological Analysis

Study Group

Study group are patient that remove the calcaneo-stop screw (age from 14 years old)

Other: Histological Analysis

Interventions

Histological Analysis OTHER

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

Control Group; Study Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (2)

Ircss Ospedale San Raffaele

Milan, Lombardy, 20149, Italy

Location

Università Vita-Salute San Raffaele

Milan, 20132, Italy

Location

Related Publications (10)

• 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.

  PMID: 34752238 BACKGROUND

• Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.

  PMID: 29381041 BACKGROUND

• 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.

  PMID: 21455468 BACKGROUND

• 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.

  PMID: 19963167 BACKGROUND

• 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.

  PMID: 23147627 BACKGROUND

• 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.

  PMID: 25413354 BACKGROUND

• 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.

  PMID: 24472004 BACKGROUND

• 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.

  PMID: 6051731 BACKGROUND

• 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.

  PMID: 16022987 BACKGROUND

• 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.

  PMID: 19963343 BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)