Subtalar Extra-articular Screw Arthroereisis
Not yet recruiting
- Conditions
- Flatfoot, Flexible
- Registration Number
- NCT06389253
- Lead Sponsor
- Università Vita-Salute San Raffaele
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint (%) Time 0 (baseline) Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue
- Secondary Outcome Measures
Name Time Method Secondary Endpoint Time 0 (baseline) Number and type of nervous fibers
Trial Locations
- Locations (2)
Ircss Ospedale San Raffaele
🇮🇹Milan, Lombardy, Italy
Università Vita-Salute San Raffaele
🇮🇹Milan, Italy
Ircss Ospedale San Raffaele🇮🇹Milan, Lombardy, Italy