Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 7:29 AM
Study NCT ID:
NCT05045157
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052582', 'term': 'Trigger Finger Disorder'}], 'ancestors': [{'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Effectiveness of pulley section with ultrasound guidance combined with corticosteroid infiltration versus corticosteroid alone on complete resolution of trigger finger's symptoms", 'timeFrame': '1 year postoperatively', 'description': "Trigger finger's symptoms defined by a clinical Quinnell score ≤1 without the use of an alternative therapy"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger']}, 'descriptionModule': {'briefSummary': 'Trigger finger is a mechanical problem characterized by pain and catching of digit in flexion.\n\nHistological changes of A1 pulley and synovial proliferation have been identified as factors that prompt trigger finger The first-line treatment of trigger finger is conservative with splinting and corticosteroid injection.\n\nIf the first infiltration fails, either a second infiltration or surgical sectioning of the pulley is proposed.\n\nSurgery can be performed by several techniques (open section, percutaneous section with palpatory guidance, or under ultrasound guidance).\n\nPercutaneous A1 pulley release under ultrasound guidance consists of cutting the A1 pulley by a percutaneous insertion with small needle under local anaesthesia.\n\nThe hypothesis of the study is that percutaneous A1 pulley release under ultrasound guidance followed by a corticosteroid injection would be more effective than a second corticosteroid injection alone on complete resolution of the trigger finger symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient ≥ 18 years old,\n* Presence of a trigger finger (thumb or long fingers) to be treated\n* Quinnell score \\>1\n* Episode of trigger characterized on questioning or clinical examination\n* Failure of a first corticosteroid infiltration \\> 3 months before inclusion\n* First infiltration within 15 months of inclusion\n* Thickening A1 pulley on ultrasound ≥ 0.5 mm\n* Patient who has the capacity to understand the protocol and has given consent to participate in the research,\n* Patient with social security coverage\n\nExclusion Criteria:\n\n* Presence of several symptomatic fingers requiring treatment by ultrasound-guided section of the pulley\n* Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion\n* Known allergy to corticoid (Hydrocortancyl®) including its excipients ((benzyl alcohol, sodium carmellose, sodium chloride, polysorbate 80)\n* Known allergies to lidocaine\n* Ongoing anticoagulant treatments (AVK, New Oral Anti-Coagulants)\n* Local or general infection, or suspicion of infection\n* Live vaccines\n* Evolving viruses (hepatitis, herpes, varicella, shingles)\n* Severe or uncontrolled hypertension\n* Unbalanced diabetes\n* Underlying progressive cardiovascular disease\n* Hemodialysis patients\n* Prosthesis on the finger to be treated\n* Echographic tendon fissure\n* Inflammatory disease (rheumatoid arthritis, spondyloarthritis, connective tissue diseases, etc.) with tenosynovitis.\n* History of surgery on the fingers\n* Dupuytren's disease\n* Patient participating in another interventional clinical research protocol involving a drug or medical device\n* Patient under guardianship, curators or legal protection"}, 'identificationModule': {'nctId': 'NCT05045157', 'acronym': 'SECOIA', 'briefTitle': 'Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Effectiveness of Percutaneous A1 Pulley Release Under Ultrasound Guidance Associated With Infiltration, Versus Infiltration Alone, in Patients With Trigger Finders Who Have Failed a First Infiltration: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CHD21_0024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'percutaneous A1 pulley release with corticosteroid injection', 'interventionNames': ['Procedure: Percutaneous A1 Pulley Release Under Ultrasound Guidance', 'Drug: Corticosteroid injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'corticosteroid injection alone', 'interventionNames': ['Drug: Corticosteroid injection']}], 'interventions': [{'name': 'Percutaneous A1 Pulley Release Under Ultrasound Guidance', 'type': 'PROCEDURE', 'description': 'the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.', 'armGroupLabels': ['percutaneous A1 pulley release with corticosteroid injection']}, {'name': 'Corticosteroid injection', 'type': 'DRUG', 'description': 'corticosteroid injection is performed', 'armGroupLabels': ['corticosteroid injection alone', 'percutaneous A1 pulley release with corticosteroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle SACCO, Dr', 'role': 'CONTACT', 'email': 'isabelle.sacco@aphp.fr', 'phone': '149812711', 'phoneExt': '+33'}], 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Grégoire CORMIER, Dr', 'role': 'CONTACT', 'email': 'gregoire.cormier@chd-vendee.fr', 'phone': '251446197', 'phoneExt': '+33'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoît LE GOFF, Dr', 'role': 'CONTACT', 'email': 'Benoit.LEGOFF@chu-nantes.fr', 'phone': '240084824', 'phoneExt': '+33'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alan GAUFFENIC, Dr', 'role': 'CONTACT', 'email': 'alan.gauffenic@aphp.fr', 'phone': '149958631', 'phoneExt': '+33'}], 'facility': 'Hopital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Clémentin GABORIAU', 'role': 'CONTACT', 'email': 'clementin.gaboriau@ght85.fr', 'phone': '02 51 44 65 72', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Grégoire Cormier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHD Vendée'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}