Clinical trial NCT06091371: Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation
Official title: Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subtalar Arthrorisis
Flat Feet
Growth Age
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 8 and 14 years with idiopathic, flexible, symptomatic flatfoot

Brief summary: Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.

Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.


Eligibility criteria: Inclusion Criteria:

* Idiopathic, flexible, symptomatic flatfoot
* Patients aged between 8 and 14 years

Exclusion Criteria:

* Joint laxity
* Neuromuscular disorders
* Neurological conditions
* Traumatic sequelae
* Iatrogenic flatfoot
* Congenital flatfoot due to tarsal synostosis

Primary outcomes:
measure: Meary's angle
timeFrame: At baseline (day 0)
measure: Meary's angle
timeFrame: After 1 month
measure: Meary's angle
timeFrame: After 3 months
measure: Meary's angle
timeFrame: After 6 months
measure: Meary's angle
timeFrame: After 12 months
measure: Meary's angle
timeFrame: After 24 months
measure: Meary's angle
timeFrame: After 36 months
measure: Meary's angle
timeFrame: After 48 months
measure: Meary's angle
timeFrame: After 72 months
Secondary outcomes:
measure: AOFAS Score
timeFrame: At baseline (day 0)
measure: AOFAS Score
timeFrame: After 1 month
measure: AOFAS Score
timeFrame: After 3 months
measure: AOFAS Score
timeFrame: After 6 months
measure: AOFAS Score
timeFrame: After 12 months
measure: AOFAS Score
timeFrame: After 24 months
measure: AOFAS Score
timeFrame: After 36 months
measure: AOFAS Score
timeFrame: After 48 months
measure: AOFAS Score
timeFrame: After 72 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Nelson SC, Haycock DM, Little ER. Flexible flatfoot treatment with arthroereisis: radiographic improvement and child health survey analysis. J Foot Ankle Surg. 2004 May-Jun;43(3):144-55. doi: 10.1053/j.jfas.2004.03.012.