Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06525532

Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA

From the archives of the IRCCS Rizzoli Orthopedic Institute, all cases of arthrorrhesis of the subtalar joint with a reabsorbable endorthotic implant in PLLA will be retrieved. An overall electronic database will be created and all medical records of these cases will be reviewed.

The eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).

The study will not present a control group or comparison groups between therapeutic procedures.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lower Limb Deformity

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Massimiliano Mosca, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 8 and 15 years at the time of surgery
  • Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA
  • Minimum follow-up of 5 years

Exclusion criteria

  • Revisions/explantation of the endorthesis device
  • Patients with active acute or chronic infections
  • Patients with chronic inflammatory joint diseases
  • Patients with previous significant trauma of the lower limbs following surgery
  • Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)
  • Patients with cognitive deficits
  • - Patients with concomitant neurological pathologies
  • Patients suffering from tumor pathology
  • Patients with cardiac pacemakers or other prostheses equipped with electronic circuits
  • Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures
  • Patients with orthopedic metal prostheses
  • Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material
  • Pregnant patients
  • Patients with insulin pumps and non-removable contact lenses

Treatment and study plan

Follow up

Other

performing a 3 Tesla MRI of the operated foot

Primary outcomes

  1. Instrumental evaluation

    Time frame: At baseline (Day 0)

    Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant

  2. evaluation of screw resorption

    Time frame: at baseline

    Clinical and Magnetic Resonance Imaging Results - PMC (nih.gov), Poly-L-lactic acid - hydroxyapatite (PLLA-HA) bioabsorbable interference screws for tibial graft fixation in anterior cruciate ligament (ACL) reconstruction surgery

Secondary outcomes

  1. clinical evaluation - Ankle-Hindfoot score

    Time frame: at baseline (day 0)

    AOFAS: this questionnaire consists of points assigned to nine items divided into three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) for a total of 100 points, the extreme of which represents a normal foot complex -ankle

  2. Quality of life - SF-12

    Time frame: at baseline

    The SF-12 health questionnaire is a standardized generic instrument for the rapid, economical and disease-free acquisition of the patient's health-related quality of life.

Study contacts

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

Massimiliano Mosca, MD

CONTACT

[email protected]

0516366

Silvio Caravelli, PhD

CONTACT

[email protected]

0516366

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up

Acronym: CS-RM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2024
Registry last updated
Dec 29, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.