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NCT Number: NCT06091371

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

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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Key information

Conditions

Subtalar Arthrorisis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flat Feet Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Growth Age Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Cesare Faldini, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Meary's angle

    Time frame: At baseline (day 0)

    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.

  2. Meary's angle

    Time frame: After 1 month

    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.

  3. Meary's angle

    Time frame: After 3 months

    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.

  4. Meary's angle

    Time frame: After 6 months

    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.

  5. Meary's angle

    Time frame: After 12 months

    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.

  6. Meary's angle

    Time frame: After 24 months

    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.

  7. Meary's angle

    Time frame: After 36 months

    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.

  8. Meary's angle

    Time frame: After 48 months

    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.

  9. Meary's angle

    Time frame: After 72 months

    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.

Secondary outcomes

  1. AOFAS Score

    Time frame: At baseline (day 0)

    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

  2. AOFAS Score

    Time frame: After 1 month

    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

  3. AOFAS Score

    Time frame: After 3 months

    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

  4. AOFAS Score

    Time frame: After 6 months

    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

  5. AOFAS Score

    Time frame: After 12 months

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

  6. AOFAS Score

    Time frame: After 24 months

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

  7. AOFAS Score

    Time frame: After 36 months

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

  8. AOFAS Score

    Time frame: After 48 months

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

  9. AOFAS Score

    Time frame: After 72 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Mazzotti, MD PhD

CONTACT

[email protected]

0516445064

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Oct 19, 2023
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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