Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01486420
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2011-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
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': 'D061887', 'term': 'Conversion to Open Surgery'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2011-12-03', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quinell grade', 'timeFrame': '12 months', 'description': 'Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.\n\nQuinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS) score', 'timeFrame': '12 weeks', 'description': 'Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)'}, {'measure': 'infection', 'timeFrame': '12 weeks', 'description': 'Infection occurence following either procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quinell grade', 'Open surgery', 'corticosteroid injections', 'randomized controlled trial', 'Trigger finger'], 'conditions': ['Trigger Finger']}, 'referencesModule': {'references': [{'pmid': '23673265', 'type': 'DERIVED', 'citation': 'Hansen RL, Lange J. Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial. Dan Med J. 2013 May;60(5):A4633.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trigger finger Quinell grade IIb-V in digit I-V\n\nExclusion Criteria:\n\n* Former treatment of Trigger finger in affected digit\n* Dupuytrens contracture in affected digit\n* Allergies or intolerance to used medications\n* Rheumatoid Arthritis\n* Insulin dependent Diabetes Mellitus\n* Amyloidosis\n* Mucopolysaccharidosis\n* Already included in study with another digit'}, 'identificationModule': {'nctId': 'NCT01486420', 'briefTitle': 'Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Silkeborg'}, 'officialTitle': 'Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'M-20110157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open surgery', 'interventionNames': ['Procedure: Open surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid Injection', 'interventionNames': ['Procedure: Corticosteroid injections']}], 'interventions': [{'name': 'Corticosteroid injections', 'type': 'PROCEDURE', 'description': 'Corticosteroid injections in and around A1-pulley.', 'armGroupLabels': ['Corticosteroid Injection']}, {'name': 'Open surgery', 'type': 'PROCEDURE', 'description': 'Open A1-pulley release', 'armGroupLabels': ['Open surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Center for Planned surgery - Regionalhospital Silkeborg', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}], 'overallOfficials': [{'name': 'Jeppe Lange, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for Planned Surgery - Regionalhospital Silkeborg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeppe Lange, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior project superviser', 'investigatorFullName': 'Jeppe Lange, MD', 'investigatorAffiliation': 'Regionshospitalet Silkeborg'}}}}