Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-02 @ 1:53 PM
Study NCT ID:
NCT06525532
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Instrumental evaluation', 'timeFrame': 'At baseline (Day 0)', 'description': 'Instrumental evaluation with 3 Tesla MRI of the degradation and possible resorption of the implant'}, {'measure': 'evaluation of screw resorption', 'timeFrame': 'at baseline', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'clinical evaluation - Ankle-Hindfoot score', 'timeFrame': 'at baseline (day 0)', 'description': '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'}, {'measure': 'Quality of life - SF-12', 'timeFrame': 'at baseline', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arthrorrhesis', 'reabsorbable endorthotic implant', 'subtalar joint', 'pediatric joint implant'], 'conditions': ['Lower Limb Deformity']}, 'referencesModule': {'references': [{'pmid': '21323297', 'type': 'RESULT', 'citation': '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': '24259795', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe eligibility of each individual patient will be assessed on the basis of the exclusion and inclusion criteria (non-probability convenience sampling).\n\nThe study will not present a control group or comparison groups between therapeutic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 8 and 15 years at the time of surgery\n* Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA\n* Minimum follow-up of 5 years\n\nExclusion Criteria:\n\n* Revisions/explantation of the endorthesis device\n* Patients with active acute or chronic infections\n* Patients with chronic inflammatory joint diseases\n* Patients with previous significant trauma of the lower limbs following surgery\n* Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias)\n* Patients with cognitive deficits\n* \\- Patients with concomitant neurological pathologies\n* Patients suffering from tumor pathology\n* Patients with cardiac pacemakers or other prostheses equipped with electronic circuits\n* 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\n* Patients with orthopedic metal prostheses\n* Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material\n* Pregnant patients\n* Patients with insulin pumps and non-removable contact lenses'}, 'identificationModule': {'nctId': 'NCT06525532', 'acronym': 'CS-RM', 'briefTitle': 'Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Reabsorbable Endorthesis Implant in PLLA', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Clinical-MRI Evaluation in Patients Undergoing Subtalar Arthrorisis With Resorbable PLLA Endothesis Implant: Prospective Observational Study at 5 Years of Minimum Follow-up', 'orgStudyIdInfo': {'id': 'CS-RM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'subjects who have undergone surgery for subtalar arthroritis with a reabsorbable endorthotic PLLA implant', 'interventionNames': ['Other: follow up']}], 'interventions': [{'name': 'follow up', 'type': 'OTHER', 'description': 'performing a 3 Tesla MRI of the operated foot', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimiliano Mosca, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Massimiliano Mosca, MD', 'role': 'CONTACT', 'email': 'massimiliano.mosca@ior.it', 'phone': '0516366'}, {'name': 'Silvio Caravelli, PhD', 'role': 'CONTACT', 'email': 'silvio.caravelli@ior.it', 'phone': '0516366'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}