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

NCT ID: NCT06091371

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Subtalar Arthrorisis Flat Feet Growth Age

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Antonio Mazzotti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Mazzotti, MD PhD

Role: CONTACT

0516445064

Facility Contacts

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Cesare Faldini, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 15181430 (View on PubMed)

Other Identifiers

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EPProsp

Identifier Type: -

Identifier Source: org_study_id

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