Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for Flexible Flatfoot Treatment During the Growth Age Prospective Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-14
SponsorIstituto Ortopedico Rizzoli

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Idiopathic, flexible, symptomatic flatfoot

Patients aged between 8 and 14 years

Disqualifiers

Joint laxity

Neuromuscular disorders

Neurological conditions

Traumatic sequelae

Trial population

Patients aged between 8 and 14 years with idiopathic, flexible, symptomatic flatfoot

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Meary's angle

Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

Time frame
At baseline (day 0)
2

Meary's angle

Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

Time frame
After 1 month
3

Meary's angle

Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

Time frame
After 3 months
4

Meary's angle

Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

Time frame
After 6 months

Secondary outcomes

1

AOFAS Score

The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score

Time frame
At baseline (day 0)
2

AOFAS Score

The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score

Time frame
After 1 month
3

AOFAS Score

The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score

Time frame
After 3 months
4

AOFAS Score

The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score

Time frame
After 6 months

Other outcomes

Sponsors and contacts

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