Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:03 AM
Study NCT ID:
NCT07375134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study - Heel Syndrome and Relationship to Flexor Retinacular Ligament Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).', 'timeFrame': 'perioperatively', 'description': 'Intraoperative measurement of flexor retinacular ligament thickness'}], 'secondaryOutcomes': [{'measure': 'Assess the existence of other factors that may be related to the occurrence of hand heel syndrome (Spontaneous pain) according to the initial characteristics and follow-up data of patients with and without hand heel syndrome.', 'timeFrame': 'Baseline to six months after the surgery', 'description': 'Spontaneous pain in the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).'}, {'measure': 'Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Pain on palpation of the heel of the hand) based on initial characteristics and follow-up data, patients with and without hand heel syndrome', 'timeFrame': 'Baseline to six months after the surgery', 'description': 'Pain on palpation of the heel of the hand assessed by the patient on a simple numeric rating scale (SNS) from 0 to 10 (0 = no pain, 10 = maximum pain).'}, {'measure': 'Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Postoperative complications) based on follow-up data, patients with and without hand heel syndrome', 'timeFrame': 'Immediately after the intervention to six months postoperatory', 'description': 'Postoperative complications (inflammatory scar or keloid, complex regional pain syndrome, infection or hematoma).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heel pain syndrome', 'patients operated on for carpal tunnel syndrome', 'thickness of the flexor retinacular ligament'], 'conditions': ['Carpal Tunnel Syndrome (CTS)', 'Heel Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. These studies have shown that the thickness of the ligament is greater in patients with carpal tunnel syndrome, without, however, demonstrating that it is related to the onset of this syndrome. According to Bartolomé-Villar, it may rather influence the onset of carpal pain.\n\nThe objective of this study is to determine whether a relationship exists between the thickness of the flexor retinacular ligament and the development of heel syndrome in the postoperative period for carpal tunnel syndrome.', 'detailedDescription': 'This is a prospective, longitudinal, single-center, open-label observational study conducted on a population of patients operated on for carpal tunnel syndrome.\n\nThis study does not alter patient care or the doctor-patient relationship. Evaluations take place during routinely scheduled consultations. The frequency of evaluations is consistent with standard postoperative follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated on for carpal tunnel syndrome by the same operator using the Chow technique.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Male or female patient over 18 years of age\n* Patient who has been informed of the research and has not indicated their opposition to the use of their medical data\n* Patient who is a candidate for first-time carpal tunnel surgery\n\nExclusion Criteria :\n\n* Emergency surgery performed in a post-traumatic context\n* Mental impairment or any other reason that may hinder understanding or strict application of the protocol\n* Patient not affiliated with the French social security system\n* Patient under legal protection, guardianship, or curatorship\n* Patient already included in another therapeutic study protocol'}, 'identificationModule': {'nctId': 'NCT07375134', 'acronym': 'ESTEREL', 'briefTitle': 'Observational Study - Heel Syndrome and Relationship to Flexor Retinacular Ligament Thickness', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Evaluation of the Relationship Between Flexor Retinacular Ligament Thickness and the Development of Heel Pain Syndrome After Carpal Tunnel Surgery.', 'orgStudyIdInfo': {'id': 'COS-RGDS-2023-12-034-P-DINH-A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with heel-of-hand syndrome 6 months after surgery for carpal tunnel syndrome', 'description': 'Patients with heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)'}, {'label': 'Patients without heel of the hand syndrome 6 months after surgery for carpal tunnel syndrome', 'description': 'Patients without heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94500', 'city': 'Champigny-sur-Marne', 'country': 'France', 'facility': "Hôpital Privé Paul d'Egine", 'geoPoint': {'lat': 48.81642, 'lon': 2.49366}}], 'overallOfficials': [{'name': 'Antonio DINH, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hôpital Privé Paul d'Egine"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}