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RecruitingNCT06091371Updated Aug 2, 2024

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

An observational study in Subtalar Arthrorisis, Flat Feet and Growth Age, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
55
Ages
8 Years to 14 Years
Sex
All
01

Study 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.

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Conditions studied

  • Subtalar Arthrorisis
  • Flat Feet
  • Growth Age

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03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 55 is above the median of 47 across 48 observational studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Joint laxity
  • Neuromuscular disorders
  • Neurological conditions
  • Traumatic sequelae
  • Iatrogenic flatfoot
  • Congenital flatfoot due to tarsal synostosis
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
55 participants (estimated)
Target follow-up
6 Years
Patient registry
Yes
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What researchers measure

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

  5. 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 12 months

  6. 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 24 months

  7. 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 36 months

  8. 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 48 months

  9. 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 72 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

  5. AOFAS Score

    American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score

    Time frame: After 12 months

  6. AOFAS Score

    American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score

    Time frame: After 24 months

  7. AOFAS Score

    American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score

    Time frame: After 36 months

  8. AOFAS Score

    American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score

    Time frame: After 48 months

  9. AOFAS Score

    American Orthopaedic Foot and Ankle Society Score- from 0 to 100 points. 0 worst possible score, 100 best possible score

    Time frame: After 72 months

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 15181430 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06091371
Responsible party
Antonio Mazzotti (Principal Investigator, Istituto Ortopedico Rizzoli) — Principal investigator
First posted
Oct 19, 2023
Start date
Jul 1, 2022
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 2, 2024

Study contacts

Antonio Mazzotti, MD PhD
Contact
antonio.mazzotti@ior.it
0516445064

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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