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

NCT06525532 | Recruiting

• 1 other identifier: CS-RM
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Deformity

Keywords

arthrorrhesis; reabsorbable endorthotic implant; subtalar joint; pediatric joint implant

Outcome Measures

Primary Outcomes (2)

• Instrumental evaluation

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

  At baseline (Day 0)

• evaluation of screw resorption

  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

  at baseline

Secondary Outcomes (2)

• clinical evaluation - Ankle-Hindfoot score

  at baseline (day 0)

• Quality of life - SF-12

  at baseline

Study Arms (1)

Patients

subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant

Other: follow up

Interventions

follow up OTHER

performing a 3 Tesla MRI of the operated foot

Patients

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (2)

• Benedetti MG, Ceccarelli F, Berti L, Luciani D, Catani F, Boschi M, Giannini S. Diagnosis of flexible flatfoot in children: a systematic clinical approach. Orthopedics. 2011 Jan 1;34(2):94. doi: 10.3928/01477447-20101221-04.

  PMID: 21323297 RESULT

• Kim MK, Lee YS. Kinematic analysis of the lower extremities of subjects with flat feet at different gait speeds. J Phys Ther Sci. 2013 May;25(5):531-3. doi: 10.1589/jpts.25.531. Epub 2013 Jun 29.

  PMID: 24259795 RESULT

Central Study Contacts

Massimiliano Mosca, MD

CONTACT

0516366; massimiliano.mosca@ior.it

Silvio Caravelli, PhD

CONTACT

0516366; silvio.caravelli@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

IT (1)