Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-09 @ 6:57 AM
Study NCT ID:
NCT03679793
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2018-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Open and Percutaneous Release of Acquired Trigger Thumb
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-19', 'studyFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume of local anaesthetics injected', 'timeFrame': 'Intra-operative', 'description': 'The total volume of local anaesthetics injected during operation'}, {'measure': 'Duration of surgery (in minutes)', 'timeFrame': 'Intra-operative', 'description': 'The time (in minutes) needed for operation'}, {'measure': 'Surgical site pain', 'timeFrame': 'Intra-operative', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)'}, {'measure': 'Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)', 'timeFrame': 'Pre-operative', 'description': 'Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness'}, {'measure': 'Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)', 'timeFrame': 'Post-op Day 7', 'description': 'Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness'}, {'measure': 'Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)', 'timeFrame': 'Post-op Day 28', 'description': 'Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness'}, {'measure': 'Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)', 'timeFrame': 'Post-op Day 90', 'description': 'Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness'}, {'measure': 'Pre-operative Kapandji score', 'timeFrame': 'Pre-operative', 'description': 'Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.'}, {'measure': 'Post-operative Kapandi score', 'timeFrame': 'Post-op Day 7', 'description': 'Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.'}, {'measure': 'Post-operative Kapandi score', 'timeFrame': 'Post-op Day 28', 'description': 'Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.'}, {'measure': 'Post-operative Kapandi score', 'timeFrame': 'Post-op Day 90', 'description': 'Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.'}, {'measure': 'Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work', 'timeFrame': 'Pre-operative', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.'}, {'measure': 'Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work', 'timeFrame': 'Post-op Day 7', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.'}, {'measure': 'Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work', 'timeFrame': 'Post-op Day 28', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.'}, {'measure': 'Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work', 'timeFrame': 'Post-op Day 90', 'description': 'The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.'}, {'measure': 'Pre-operative pain at rest', 'timeFrame': 'Pre-opeartively', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain at rest', 'timeFrame': 'Post-op Day 7', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain at rest', 'timeFrame': 'Post-op Day 28', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain at rest', 'timeFrame': 'Post-op Day 90', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)'}, {'measure': 'Pre-operative pain on exertion', 'timeFrame': 'Pre-operative', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain on exertion', 'timeFrame': 'Post-op Day 7', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain on exertion', 'timeFrame': 'Post-op Day 28', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)'}, {'measure': 'Post-operative pain on exertion', 'timeFrame': 'Post-op Day 90', 'description': 'Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)'}, {'measure': 'Satisfaction level after surgery', 'timeFrame': 'Post-op Day 7', 'description': "Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery"}, {'measure': 'Satisfaction level after surgery', 'timeFrame': 'Post-op Day 28', 'description': "Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery"}, {'measure': 'Satisfaction level after surgery', 'timeFrame': 'Post-op Day 91', 'description': "Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigger Finger Disorder', 'Trigger Thumb', 'Minimally Invasive Surgical Procedures', 'Orthopedics'], 'conditions': ['Trigger Thumb']}, 'descriptionModule': {'briefSummary': 'Trigger finger, also known as trigger digit or stenosing tenovaginitis, is caused by a size mismatch between the flexor tendon and the A1 pulley, which is generally characterized by pain, swelling, the limitation of finger range of motion and a symptomatic locking or clicking sensation. Conservative treatment options include the application of non-steroidal anti-inflammatory drugs (NSAID), physiotherapy, electrotherapy, splinting and corticosteroid injection but not always effective with regard to frequent recurrence. Open surgical release of the A1 pulley remains the gold standard of treating symptomatic trigger finger. While percutaneous release is a minimal invasive alternative and gaining popularity for the index, middle ring and little fingers, investigations for the surgical efficacy on thumb is few and far between. Investigators believe that a carefully conducted operation with proper positioning of the thumb, wide-awake approach and meticulous technique can achieve similar efficacy and safety in terms of possibly less intraoperative pain, imperceptible scar and early return to daily activities and routine work.\n\nThe hypothesis of this study is that by using a proper positioning of thumb, wide awake approach and meticulous technique in conducting percutaneous release of trigger thumb can achieve similar efficacy and safety compared to that of open release surgical method. Moreover, percutaneous release of trigger thumb can generate less intraoperative pain, imperceptible scar and promote early return to routine work.\n\nHence, the objective of this study is to investigate and compare the safety, effectiveness and outcome of percutaneous release versus traditional open release for trigger thumbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of trigger thumb with Green's staging graded 2-4\n* Patients were unresponsive to conservative treatments for more than 3 months (Nonsteroidal anti-inflammatory drugs, physiotherapy, splinting, or injection of steroid)\n\nExclusion Criteria:\n\n* With history in rheumatoid arthritis\n* Unable to give verbal or written consent."}, 'identificationModule': {'nctId': 'NCT03679793', 'briefTitle': 'Study of Open and Percutaneous Release of Acquired Trigger Thumb', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb', 'orgStudyIdInfo': {'id': 'Trigger thumb_Protocol_v02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open Release Group', 'description': 'Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.', 'interventionNames': ['Procedure: Open Release Group']}, {'type': 'EXPERIMENTAL', 'label': 'Percutaneous Release Group', 'description': 'Percutaneous release is a minimal invasive alternative surgical procedure', 'interventionNames': ['Procedure: Percutaneous Release Group']}], 'interventions': [{'name': 'Open Release Group', 'type': 'PROCEDURE', 'description': 'Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger', 'armGroupLabels': ['Open Release Group']}, {'name': 'Percutaneous Release Group', 'type': 'PROCEDURE', 'description': 'Percutaneous release is a minimal invasive alternative surgical procedure', 'armGroupLabels': ['Percutaneous Release Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All collected data were from patients from study site and strictly confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant and Clinical Associate Professor (Honorary)', 'investigatorFullName': 'Dr TSE Wing Lim', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}