Clinical trial NCT06389253: Subtalar Extra-articular Screw Arthroereisis
Official title: Subtalar Extra-articular Screw Arthroereisis: How Does the Screw Work
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Flatfoot, Flexible
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint (%)
timeFrame: Time 0 (baseline)
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: Time 0 (baseline)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ircss Ospedale San Raffaele
state: Lombardy
city: Milan
country: Italy
facility: Università Vita-Salute San Raffaele
Study officials:
References:
citation: 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.
citation: Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.